Injectable Poly-L-Lactic Acid: Understanding Its Use in the Current Era.

A survey of Sculptra® Aesthetic injectors was conducted to understand how the product is being currently reconstituted and injected. Questions were asked of injectors to understand their reasons for choice and volume of diluent(s), additions, and time for the reconstitution process. These results are discussed in the context of the past history of the product over the last decade, with a focus on adverse events such as papules and nodules.

J Drugs Dermatol. 2016;15(6):759-762.

Effectiveness and safety of once-daily doxycycline capsules as monotherapy in patients with rosacea: an analysis by Fitzpatrick skin type.

Rosacea is often under-recognized or misdiagnosed in patients with skin of color (Fitzpatrick Skin Types [FST] IV-VI). Subtle clinical features and a low index of suspicion likely contribute to less frequent diagnosis in this population. Clinical trials of therapeutic agents for rosacea generally include few patients from nonwhite racial/ethnic groups and therefore, potential differences in treatment outcomes have not been previously studied. The objective of this prospective analysis was to fill the gap in knowledge of the effectiveness and safety of treatment for rosacea in patients with skin of color. We analyzed data from 826 adults aged ≥ 18 years with papulopustular (subtype 2) rosacea (663 FST I-III; 163 FST IV-VI). All patients received doxycycline 40 mg capsules (30 mg immediate release and 10 mg delayed release beads) once daily as monotherapy for 12 weeks in this open-label, multicenter, community-based study. Investigators assessed disease severity with the Investigator's Global Assessment (IGA) and erythema with the Clinician's Erythema Assessment (CEA). Significant improvement in disease severity and erythema was obtained in patients with FST I-III and IV-VI at week 12 (P<.001). Treatment success, defined as an IGA score of 0 or 1 was achieved in 74.6% and 74.3% of patients with FST I-III and IV-VI, respectively. Approximately 12% of patients experienced adverse events with no difference between the two skin type groups. The results of this prospective subgroup analysis of data from a large community-based trial suggest that doxycycline produced similar effectiveness and safety profiles in patients with FST I-III and IV-VI.

Impact of clobetasol propionate 0.05% spray on health-related quality of life in patients with plaque psoriasis.

Psoriasis causes significant distress and impairment in health-related quality of life (QOL) in afflicted patients. For this reason, QOL is an essential and important measure of treatment outcome in patients with the disease. Clobetasol propionate is a super-highpotent class I topical corticosteroid. The spray formulation is approved for twice-daily use for up to 4 weeks by patients 18 years and older with moderate to severe plaque psoriasis. Data collected from 2,236 patients enrolled in 5 clinical trials demonstrate consistent improvement in QOL measures using multiple instruments. In a randomized, double-blind trial in patients with scalp psoriasis, treatment with clobetasol propionate 0.05% spray produced significantly greater improvement in QOL compared with vehicle, as measured by the Scalpdex QOL instrument. In another randomized trial in patients with moderate to severe plaque psoriasis, clobetasol propionate 0.05% spray produced significantly greater reductions in mean affected body surface area and significantly greater improvements in QOL, as measured by the Dermatology Life Quality Index (DLQI), compared with a 0.05% foam formulation. When compared with calcipotriene/betamethasone dipropionate ointment, clobetasol propionate 0.05% spray produced greater rates of lesion clearance and similar improvement in QOL scores after 2 or 4 weeks of treatment. When clobetasol propionate 0.05% spray was used as monotherapy or as an add-on therapy for 4 weeks in a large, observational trial, approximately 80% of patients experienced consistent and significant improvement in QOL on 2 separate, validated QOL instruments (DLQI and the Koo-Menter Psoriasis Index). In conclusion, clobetasol propionate 0.05% spray is an efficacious and safe treatment for plaque psoriasis and produces significant improvement in QOL for affected patients.

Digital videography assessment of patients' experiences using adapalene-benzoyl peroxide gel in the treatment of acne vulgaris.

BACKGROUND: Acne profoundly affects patients' lives, but the effect of treatment is not fully characterized. OBJECTIVE: The purpose of this study was to explore patients' experiences and viewpoints regarding treatment for mild to moderate acne vulgaris. METHODS: This was an open-label, single-center study of 30 patients with mild to moderate acne vulgaris, treated with adapalene 0.1%/benzoyl peroxide 2.5% (adapalene-BPO gel) once daily for 12 weeks. An acne-specific quality of life questionnaire (Acne-QoL©) was conducted. Each subject's global assessment (SGA) was recorded at baseline and weeks 4, 8, and 12. Photographs were taken and video interviews were recorded. Local tolerability assessments and incidence of adverse events were documented. RESULTS: A statistically significant number of patients were clear/almost clear (treatment success) at week 12 (P<.001). At week 12, patients experienced a 44.1% and 57.1% mean reduction in inflammatory and noninflammatory lesions, respectively. By week 12, 67% of the patients in the video population (n=27) believed they had achieved treatment success (P<.001). Patients reported higher Acne-QoL© scores at week 12 compared to baseline, indicating better quality of life after treatment with adapalene-BPO gel (P<.001 for all domains). No unexpected adverse or serious adverse events were reported. LIMITATIONS: This was an open-label study of 12 weeks duration. CONCLUSION: Overall, patients with mild to moderate acne treated with adapalene-BPO gel showed significant improvement in disease severity and quality of life. The video recordings chronicled the patients' experiences throughout the treatment process.

Safety and tolerability of a body wash and moisturizer when applied to infants and toddlers with a history of atopic dermatitis: results from an open-label study.

Improving skin barrier function and moisturizing without irritation are important components of managing patients with atopic dermatitis. This study evaluated the safety and tolerability of a body wash and moisturizer regimen for infants and toddlers with atopic dermatitis. This was an open-label study involving 56 children (3-36 months old) with a history of atopic dermatitis. The skin care regimen (Cetaphil Restoraderm Skin Restoring Body Wash and Cetaphil Restoraderm Skin Restoring Moisturizer; Galderma Laboratories, L.P.) was used at least once daily, but no more than twice daily, for 4 weeks. The primary variable of interest was the worst postbaseline scores for local tolerability (expressed as success or failure) using a 4-point scale for each component (erythema, edema, scaling and dryness, rash, and signs of discomfort upon application). Assessments of moisture content of the stratum corneum and transepidermal water loss were also performed. Fifty-three children completed the study. The percentage of subjects with no erythema increased from 33.9% to 50.0% by Week 4. The percentage of subjects with no scaling or dryness increased from 58.9% to 85.2% at Week 4. A statistically significant increase in corneometry from baseline (p < 0.001) and a statistically significant decrease in transepidermal water loss (p = .009) were observed. The body wash and moisturizer regimen was safe and well tolerated and improved hydration and skin barrier function in infants and toddlers as young as 3 months of age with a history of atopic dermatitis.

A comparison of the tolerability of adapalene 0.1% cream and adapalene 0.1% lotion in healthy individuals.

Two separate single-center, randomized, evaluator-blinded, bilateral (split-face) comparison studies compared the tolerability of adapalene 0.1% cream with adapalene 0.1% lotion in individuals with healthy skin treated once per day for 3 weeks. At each visit, the participants were graded on erythema, scaling, dryness, and stinging/burning (scale: 0 = none to 3 = severe). On the final study visit, the participants completed a Cosmetic Acceptability Questionnaire. Adverse events were recorded at each study visit. A total of 144 participants were enrolled and 130 completed the studies (study 1, n = 66; study 2, n = 64). The lotion formulation was non-inferior to the cream for the success rates and tolerability assessments in both studies. The frequency distributions of worst scores of either 0 (none) or 1 (mild) (study 1; study 2) for adapalene lotion were erythema (98.5%; 40.7%), scaling (100%; 73.5%), dryness (100%; 68.8%), and stinging/burning (98.5%; 100%). The most common treatment-related adverse event was dryness (study 1, cream 2.7% [2 of 75] and lotion 4.0% [3/75]); study 2, cream 2.9% [2 of 69] and lotion 4.3% [3 of 69]. Both the adapalene 0.1% cream and 0.1% lotion formulations were well tolerated and acceptable to the study participants. The adapalene 0.1% lotion provides clinicians with a retinoid for the treatment of acne in a lotion formulation.

Effectiveness and safety of modified-release doxycycline capsules once daily for papulopustular rosacea monotherapy results from a large community-based trial in subgroups based on gender.

This article is a prospective planned analysis of data evaluating the effectiveness and safety of modified-release doxycycline capsules (30 mg immediate-release and 10 mg delayed-release beads) used once daily for up to 12 weeks in subgroups of males and females with papulopustular (subtype 2) rosacea from a large, open-label, multicenter, community-based study. A total of 1421 patients participated in the study. The per-protocol population comprised 826 patients on monotherapy, with 28.5% male participants (n=235) and 71.5% female participants (n=591). Rosacea was assessed on a 5-point investigator's global assessment (IGA) scale (0=clear, 1=near clear, 2=mild, 3=moderate, 4=severe). Erythema was also assessed on a 5-point clinician's erythema assessment (CEA) scale (0=none, 1=mild, 2=moderate, 3=significant, 4=severe). At baseline, males had a higher percentage of IGA scores of 3 (116 per 235; 49.4% versus 273 per 591; 46.2% in females) and 4 (32 per 235; 13.6% versus 35 per 591; 5.9% in females). Significant improvements in severity rating and erythema were observed in males and females as demonstrated by shifts in the distribution of IGA and CEA scores between baseline and week 12 (P<.001). Treatment success (IGA score of 0 or 1) at week 12 was achieved in 172 per 235 (73.2%) of males and in 444 per 591 (75.2%) of females. Adverse events (primarily mild or moderate gastrointestinal events) were reported in 9.9% of males and 12.8% of females. Anti-inflammatory dose doxycycline, which is administered as a 40 mg modified-release capsule once daily was effective and safe as monotherapy for papulopustular rosacea in both the female (n=591) and male (n=235) study groups. This specific 40 mg capsule delivers 30 mg immediate-release and 10 mg as delayed release using specially designed beads, and is subantimicrobial with both single and repeated dosing.

Impact of Baseline Disease Severity Over 26 and 52 Weeks of Treatment with Calcitriol Ointment 3µg/g in Patients with Mild-to-moderate Plaque Psoriasis.

OBJECTIVE: Calcitriol 3µg/g ointment has been shown to be a safe and effective treatment for adults with mild-to-moderate plaque psoriasis. This analysis evaluated the response to calcitriol 3µg/g ointment relative to baseline disease. DESIGN: Retrospective analysis of data from a 12-month safety and tolerability trial. SETTING AND PARTICIPANTS: At baseline, 40.1 percent (130/324) of patients had an affected body surface area of 11 to 20 percent, and 55.2 percent (179/324) had moderate and 25.9 percent (84/324) had severe disease according to global severity score. Patients applied calcitriol 3µg/g ointment twice daily for up to 52 weeks. MEASUREMENTS: Change in investigator's global severity scores and involved body surface area at Week 26 (N=249) and Week 52 (N=130) relative to baseline. RESULTS: Compared with baseline, most patients experienced at least a 1-grade improvement in global severity score at Weeks 26 (195/249, 78.3%) and 52 (109/130, 83.8%). Stabilization (i.e., no change in global severity score) was reported in 19.3 percent (48/249) at Week 26 and in 12.3 percent (16/130) at Week 52. Most patients also experienced at least a 1-grade improvement in body surface area involved at Weeks 26 (152/249, 61.0%) and 52 (95/130, 73.1%). Stabilization (no change in affected body surface area) was reported in 32.5 percent (81/249) at Week 26 and 24.6 percent (32/130) at Week 52. The proportion of patients experiencing improvement in global severity score and body surface area was comparable across all categories of severity and disease extent at baseline. CONCLUSION: This analysis suggests that calcitriol 3µg/g ointment use for 26 weeks (N=249) and 52 weeks (N=130) was associated with disease improvement or stabilization in most patients with plaque psoriasis.

Clobetasol propionate 0.05% spray for the management of moderate-to-severe plaque psoriasis of the scalp: results from a randomized controlled trial.

BACKGROUND: Clobetasol propionate 0.05% spray is available for treating moderate-to-severe plaque psoriasis; however, there is limited information with plaque psoriasis of the scalp. OBJECTIVE: Evaluate the efficacy, safety, and quality-of-life impact of clobetasol propionate 0.05% spray in patients with moderate to severe plaque psoriasis of the scalp. METHODS: Multicenter, randomized, double-blind, vehicle-controlled study involving 81 men and women with moderate-to-severe (Global Severity Score [GSS] = 3 or 4) plaque psoriasis of the scalp. Eligible patients were treated with clobetasol propionate 0.05% spray or vehicle spray, which was applied twice daily for up to four weeks. The primary efficacy end point was the GSS of psoriasis of the scalp after four weeks. Safety assessments included local tolerability, presence of Cushing's syndrome, and adverse events. RESULTS: At the end of treatment, 85 percent (35/41) of patients in the clobetasol propionate 0.05% spray group achieved success (GSS clear or almost clear), compared with 13 percent (5/40) in the vehicle spray group (P is less than .001). The proportion of patients treated with clobetasol propionate 0.05% spray who achieved a rating of clear (GSS = 0) after two weeks and at the end of treatment was 12 percent and 51 percent, respectively. Clobetasol propionate 0.05% spray was well tolerated, and there were no serious adverse events or reported cases of folliculitis or Cushing's syndrome. CONCLUSION: Treatment with clobetasol propionate 0.05% spray for up to four weeks is effective and well tolerated for moderate-to-severe plaque psoriasis of the scalp.

The appearance of facial foundation cosmetics applied after metronidazole gel 1%.

The purpose of this study was to assess the cosmetic appearance of commonly marketed facial cosmetics when used after the application of metronidazole gel 1%. An observational. open-label, single-site study was conducted with women (N=30) aged 20 to 75 years and diagnosed with moderate papulopustular rosacea (investigator global severity score of 3). After cleansing the face with a gentle skin cleanser, participants applied metronidazole gel 1% once daily before applying their usual facial foundation. Two surveys were conducted: (1) investigator assessment of cosmetic appearance; and (2) participant assessment of cosmetic appearance. The investigator also evaluated erythema, disease severity, and tolerability at baseline and week 2. Adverse events were collected. The 28 per-protocol (PP) participants had a mean age (standard deviation [SD]) of 54.0 (10.3) years and a mean duration (SD) of rosacea of 15.4 (13.2) years. The median response score for both the investigator and participant assessments of cosmetic appearance was 10 (best) for each survey question. Signs and symptoms of rosacea did not increase with use of metronidazole gel 1% and the participants' selected cosmetic regimen. At baseline all 28 participants were classified as having moderate erythema. At week 2, 18 (64%) participants were classified as having moderate erythema and 10 (36%) mild. At baseline all 28 (100%) participants were classified as having moderate rosacea according to the investigator global severity score. At week 2, 10 (36%) participants were classified as mild and 18 (64%) moderate. In addition, few participants reported cutaneous irritation during the study. At week 2, 10 participants had dryness, 2 had itching, 8 had scaling, and 2 had stinging/burning. According to surveys completed by the investigator and the participants themselves, most participants had a good cosmetic appearance with their facial foundation cosmetics that were applied after metronidazole gel 1%. The use of various cosmetic regimens after application of metronidazole gel 1% did not cause rosacea symptoms to worsen and treatment was well-tolerated.

In-vivo Effectiveness of Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel on Antibiotic-sensitive and Resistant Propionibacterium acnes.

BACKGROUND: A gel combination treatment containing a retinoid (adapalene 0.1%) and an antimicrobial (benzoyl peroxide 2.5%) has been shown to be an effective treatment for acne vulgaris, addressing three of the four pathogenic factors (hyperkeratinization, Propionibacterium acnes proliferation, inflammation) without contributing to the incidence of Propionibacterium acnes antibiotic resistance as neither the retinoid nor benzoyl peroxide creates selective pressure for resistance. OBJECTIVE: To evaluate the effectiveness of an adapalene-benzoyl peroxide gel combination in reducing antibiotic-sensitive and resistant strains of Propionibacterium acnes on the facial skin of volunteers. METHODS: This four-week, open-label, single-center study included 30 healthy adults with high facial Propionibacterium acnes populations [>10(4) colony-forming units per square centimeter of skin (CFU/cm(2))] and presence of subpopulations resistant to erythromycin, tetracycline, and clindamycin. The gel was applied once daily to the forehead. Cultures for total and antibiotic-resistant Propionibacterium acnes were obtained from the forehead area at screening, Baseline, Week 2, and Week 4. RESULTS: Total Propionibacterium acnes counts decreased by 1.1 log(10) CFU/cm(2) after two weeks of treatment, and by 1.6 log10 CFU/cm(2) after four weeks. All subjects had strains resistant to each of the five antibiotics at baseline. Mean counts of erythromycin and clindamycin resistant Propionibacterium acnes were high at baseline (5.37 and 5.28 log(10) CFU/cm(2), respectively) and decreased by ≥2.1 log(10) by Week 4 (P<0.001). Mean counts of strains resistant to tetracyclines were lower at baseline (3.8 to 4.2 CFU/cm(2)) and decreased by 1.9 (tetracycline), 2.4 (minocycline), and 1.3 (doxycycline) log(10) CFU/cm(2) by Week 4 (P<0.001). LIMITATIONS: Although limited in scope, the results of the present study demonstrate that the fixed-dose combination gel containing adapalene 0.1% and benzoyl peroxide 2.5% effectively inhibited both antibiotic-susceptible and antibiotic-resistant Propionibacterium acnes. In addition to reducing population densities, therapy with adapalene-benzoyl peroxide eradicated some resistant strains entirely in some individual subjects. CONCLUSION: Topical adapalene-benzoyl peroxide gel effectively reduced skin colonization by antibiotic-sensitive and antibiotic-resistant Propionibacterium acnes after four weeks. This trial was registered with ClinicalTrials.gov (http://clinicaltrials.gov/), registry number NCT00907101.

Comparative effectiveness of clinically used light sources for cutaneous protoporphyrin IX-based photodynamic therapy.

This report documents the optical characteristics of a number of photodynamic therapy (PDT) light sources of varied types, measured and indexed relative to estimated effectiveness for activation of the PDT chromaphore protoporphyrin IX (PpIX). PDT sources in use at several clinics, including intense pulsed light (IPL) sources, lasers, and continuous wave (CW) light sources, were spectroradiometrically measured and indexed relative to their overlap to an absorption spectrum of PpIX. The sources were highly disparate, varying in power from irradiance in the mW/cm(2) range for the CW sources up to ∼30 J/cm(2) per flash for the IPL sources. Our PpIX Index ranged by a factor of nearly 100 (0.008-0.630) in estimated PpIX PDT effectiveness following the distinct spectral characteristics of the light sources surveyed. Application of this PpIX Index, tempered with an understanding of the biology of the lesion being treated and effective spectrum of the light source reaching the lesion requiring therapy, provides a rational algorithm to approximate equivalent light doses prior to clinical protocols to establish equivalent patient outcomes employing alternative PDT light sources.

The impact of natural sunlight exposure on the UVB-sun protection factor (UVB-SPF) and UVA protection factor (UVA-PF) of a UVA/UVB SPF 50 sunscreen.

OBJECTIVE: To compare the functional stability of Cetaphil UVA/UVB Defense SPF 50 as measured by its ultraviolet B sun protection factor (UVB-SPF) and ultraviolet A protection factor (UVA-PF) values following exposure to natural sunlight versus the UVB-SPF and UVA-PF values of unexposed product. METHODS: These two randomized, controlled, evaluator-blinded, single-center trials were conducted according to the methods outlined in the 2007 Proposed Amendment to the Final Monograph, "Sunscreen Drug Products for Over-the-Counter Human Use." Sunscreen samples were applied to glass plates and exposed to ultraviolet radiation in the form of natural sunlight in four minimal erythemal doses (MED) ranging from 2­6 MED (42­36 mJ/cm2). Three test sites were identified on the back of each study subject. Exposed sunscreen (one of four doses), unexposed sunscreen, and a UVB-SPF 15 control sunscreen were applied to the three test sites in a randomized fashion, followed by UV irradiation of incremental doses. Erythema and pigment darkening responses were assessed immediately following UV exposure and again 16­24 hours (erythema) or three to 24 hours (pigment darkening) after exposure. UVB-SPF and UVA-PF values were calculated for the exposed and unexposed samples. RESULTS: The calculated UVB-SPF and UVA-PF values for all test samples (exposed and unexposed) were >50 and >9, respectively, which were greater than the stated UVB-SPF and UVA-PF values on the product label. No differences were observed between the exposed and unexposed samples in UVB-SPF or UVA-PF. CONCLUSION: The UVA and UVB protection using standard evaluation techniques of Cetaphil UVA/UVB Defense SPF 50 remains stable despite exposure of the sunscreen to natural sunlight containing UVB ranging from 2­16 MED (41­336 mJ/cm2) and coexistent UVA.

A multi-center, open-label study to evaluate the safety and efficacy of a sequential treatment regimen of clobetasol propionate 0.05% spray followed by Calcitriol 3 mg/g ointment in the management of plaque psoriasis.

BACKGROUND: Psoriasis is a hyperproliferative and inflammatory skin disorder that affects roughly 2 percent of the worldwide population. Clobetasol propionate is the most common corticosteroid used to treat moderate-to-severe psoriasis but the potential for side effects limits its long-term use. Topical vitamin D, which is used to treat mild-to-moderate psoriasis, has been shown to be safe when used daily for up to 52 weeks. To date, very few studies exist evaluating the use of clobetasol propionate in a regimen with calcitriol to manage moderate-to-severe disease over time. OBJECTIVES: To evaluate the efficacy and assess safety of a regimen of sequential topical treatments with clobetasol propionate 0.05% spray for up to four weeks followed by calcitriol 3 µg/g ointment for eight weeks in the management of moderate-to-severe plaque psoriasis. METHODS: This was a multi-center, open-label study in subjects aged 18-80 years with moderate-to-severe plaque psoriasis at baseline. Subjects applied clobetasol propionate 0.05% spray twice daily for up to four weeks. At the end of four weeks, if the subject's overall disease severity (ODS) was assessed as clear, almost clear, mild or moderate, subjects started treatment with calcitriol 3 µg/g ointment twice daily. Twice-daily treatment with calcitriol 3 µg/g ointment continued for eight weeks (until week 12) or unless the subject's ODS was assessed as severe or returned to the baseline score, at which time it was discontinued. Subjects were evaluated at baseline and at weeks 2, 4, 8 and 12. RESULTS: Of the 305 subjects enrolled, 170 subjects completed the full 12-week study with no major protocol deviations and comprised the per-protocol (PP) study population. Treatment success, defined as at least one grade improvement in ODS at week 12 compared to baseline, was achieved in 84.1 percent of subjects. The percent body surface area affected (% BSA) decreased from 7.1 percent at baseline to 3.9 percent at week 12 (P<0.001). The sequential treatment regimen was well tolerated with no unexpected adverse events. Most reported adverse events and cutaneous irritations were mild in severity. CONCLUSIONS: The results of this study indicate that the 12-week regimen of clobetasol propionate 0.05% spray treatment for four weeks immediately followed by an eight-week treatment phase with calcitriol 3 µg/g ointment is efficacious and safe for the management of moderate-to-severe plaque psoriasis.

Sequential treatment with triple combination cream and intense pulsed light is more efficacious than sequential treatment with an inactive (control) cream and intense pulsed light in patients with moderate to severe melasma.

BACKGROUND: Triple combination (TC) cream is a stable combination of fluocinolone acetonide 0.01%, hydroquinone 4%, and tretinoin 0.05% and is currently the only hydroquinone-containing drug approved by the Food and Drug Administration for the treatment of melasma. OBJECTIVE: To evaluate the safety and efficacy of TC cream when used sequentially with intense pulsed light (IPL) treatments in patients with moderate to severe melasma. MATERIALS & METHODS: This was a 10-week, split-face study in which 56 patients with symmetrical melasma lesions were treated with TC cream on one side of the face and an inactive control cream on the other side of the face. Patients also had two IPL treatments at weeks 2 and 6. (Topical treatment was suspended during IPL treatments ± 1 day.) RESULTS: Melasma severity was significantly less with TC cream and IPL than with inactive cream and IPL at weeks 6 (p=.007) and 10 (p=.002). Improvement in melasma was greater with TC cream and IPL than with inactive cream and IPL according to investigator and patient evaluations at weeks 6 and 10 (p<.001 for both time points). Treatment with TC cream and IPL was well tolerated. CONCLUSION: The results of this study suggest that TC cream and IPL treatment is an effective and safe treatment option for patients with melasma.

Reliability assessment and validation of the Melasma Area and Severity Index (MASI) and a new modified MASI scoring method.

BACKGROUND: The Melasma Area and Severity Index (MASI), the most commonly used outcome measure for melasma, has not been validated. OBJECTIVE: We sought to determine the reliability and validity of the MASI. METHODS: After standardized training, 6 raters independently rated 21 patients with mild to severe melasma once daily over a period of 2 days to determine intrarater and interrater reliability. Validation was performed by comparing the MASI with the melasma severity scale. The darkness component of the MASI was validated by comparing it with the difference between mexameter scores for affected versus adjacent normal-appearing skin. The area component of the MASI was validated by comparing it with the area of each section of the face determined by computer-based measurement software. RESULTS: The MASI score showed good reliability within and between raters and was found to be valid when compared with the melasma severity scale, mexameter scores, and area measurements. Homogeneity assessment by raters showed the least agreement and can be removed from the MASI score without any loss of reliability. LIMITATIONS: Patients were limited to Hispanic, African, and Asian backgrounds. CONCLUSION: The MASI is a reliable measure of melasma severity. Area of involvement and darkness are sufficient for accurate measurement of the severity of melasma and homogeneity can be eliminated.

A Meta-analysis to Investigate the Relation Between Fitzpatrick Skin Types and Tolerability of Adapalene-Benzoyl Peroxide Topical Gel in Subjects with Mild or Moderate Acne.

The overall goal of acne management for all patients is to select treatments that effectively address as many pathogenic factors as possible while minimizing side effects. Acne therapy in darker skin patients presents unique challenges due to differences in the risk of postinflammatory hyperpigmentation, which may develop in response to acne itself or to irritation secondary to treatment. One combination treatment currently available is a gel formulation containing a retinoid (adapalene 0.1%) in fixed combination with an antimicrobial (benzoyl peroxide 2.5%). Results from three randomized, double-blind, vehicle-controlled, clinical trials of adapalene-benzoyl peroxide were combined in a retrospective meta-analysis that included 909 patients treated for 12 weeks and assessed at each visit for erythema, scaling, dryness, and stinging/burning. Only Week 1 results were included in the meta-analysis because the worst severity of cutaneous irritation was found to occur at this timepoint in all three trials. For each study, and for the meta-analysis, comparisons were made using the Cochran-Mantel-Haenszel test. There were no statistically significant differences in dryness, scaling, and stinging/burning with adapalene-benzoyl peroxide treatment when subjects with Fitzpatrick skin types I to III were compared to subjects with Fitzpatrick skin types IV to VI (P=NS). Erythema assessments were statistically different based on skin types, as subjects with Fitzpatrick skin types IV to VI were rated as having "none" more often than those with Fitzpatrick skin types I to III (P<0.001). This could be due to the difficulty in visualizing erythema in patients with darker skin types, mainly Fitzpatrick skin types VI. Acne patients with Fitzpatrick skin types IV to VI were not found to be more susceptible to cutaneous irritation from treatment with the adapalene-benzoyl peroxide gel than patients with Fitzpatrick skin types I to III.

Continuous therapy followed by a maintenance therapy regimen with a triple combination cream for melasma.

BACKGROUND: Melasma is often recalcitrant to treatment. Triple combination (TC) cream is an effective and approved treatment for melasma. OBJECTIVE: We sought to determine the efficacy and safety of continuous therapy followed by a maintenance treatment regimen during a period of 24 weeks with a TC cream containing hydroquinone 4%, tretinoin 0.05%, and fluocinolone acetonide 0.01%. METHODS: Seventy patients with melasma were treated with a TC cream daily for 12 weeks, after which, if clear or almost clear, they applied the cream twice per week for 12 more weeks. For patients who were not clear or almost clear after 12 weeks, daily treatment was continued. RESULTS: In all, 25 patients completing the study per protocol were treated daily for 24 weeks (cohort A); 6 patients were treated daily for 12 weeks followed by 12 weeks of maintenance therapy (cohort B); and 21 patients were treated daily for 12 weeks, relapsed during the maintenance phase, and returned to daily dosing (cohort C). Pigmentation was significantly reduced at weeks 12 and 24 and global melasma severity improved at week 24 in cohorts A and C compared with baseline. Adverse events occurred in 53% of patients and were primarily mild in severity. LIMITATIONS: This was an open-label trial. CONCLUSION: About half of patients treated with a TC cream for melasma were able to begin maintenance therapy twice per week after 12 weeks; however, relapses occurred in most of these patients, requiring resumption of daily therapy. The cream is safe in the treatment of moderate to severe melasma for up to 24 weeks when used intermittently or continuously. Significant reductions in melasma severity scores were seen at weeks 12 and 24 when compared with baseline scores in all evaluable study groups.

Comparing clobetasol propionate 0.05% spray to calcipotriene 0.005% betamethasone dipropionate 0.064% ointment for the treatment of moderate to severe plaque psoriasis.

Topical corticosteroids are widely used in the treatment of psoriasis. This study was conducted to compare the efficacy and safety of clobetasol propionate (CP) 0.005% spray to calcipotriene 0.005%-betamethasome diproprionate 0.064% (C-BD) ointment in patients with moderate to severe plaque psoriasis. Assessments were made at baseline, week 2, week 4 (end of treatment) and week 8 (4 weeks posttreatment). An assessment for Overall Disease Severity (ODS) found that 75% of CP spray-treated patients achieved a rating of clear or almost clear after 4 weeks of treatment compared to 45% of C-BD ointment-treated patients (P=.003). Adverse events were reported by less than one-third of patients from each treatment group (31% for CP spray and 33% for C-BD ointment).