[Clinical and psychological correlation in acne: use of the ECLA and CADI scales]. / Corrélation clinique et psychologique dans l'acné: utilisation des grilles ECLA et CADI.

BACKGROUND: The psychological consequences of acne are frequently unrelated to the severity of the actual lesions. Thus, a number of scales have been designed and validated to allow quantitation of the severity of acne, such as the ECLA scale (Echelle de Cotation des Lésions d'Acné or Acne Lesion Score Scale) while others are designed to evaluate quality of life, such as the CADI (Cardiff Acne Disability Index) questionnaire recently validated in the French language. The purpose of this study was to use both of these scales in individual applications in order to determine whether or not any correlation exists between the two specific tools and to determine the two groups of patients affected by acne. METHODS: One hundred and twenty-eight acne patients (21+/-6.8 years) seen by seven dermatologists were included in this study. The severity of their acne was evaluated using the ECLA scale; the seven participating dermatologists were trained in the use of this scoring system. In addition, patients completed the CADI quality-of-life questionnaire after their consultation. Each factor on the ECLA was compared with each item in the CADI questionnaire by means of analysis of variance. RESULTS: There was no correlation between overall scores on the ECLA and CADI scales (r(2)=0.0242). However, a positive correlation was observed between overall CADI score and factors F1 and F3 in the ECLA scale (p=0.0085 and p=0.0373 respectively). In contrast, the global score on the ECLA scale was significantly correlated with item 5 of the CADI questionnaire, namely patients' perception of their acne (p=0.0035). CONCLUSION: Acne, even in mild forms, has a detrimental psychological effect on patients. The ECLA score coupled with the CADI assessment system appear to be two useful and complementary scores for use in complete acne patient management.

Results of a randomised, multicentre study comparing a new water-based gel of clindamycin 1% versus clindamycin 1% topical solution in the treatment of acne vulgaris.

Several topical formulations of clindamycin phosphate are currently marketed for the treatment of acne vulgaris. This 12 week, multi-centre, investigator-blind, randomised, active and placebo-controlled, parallel group study assessed the clinical efficacy and safety of clindamycin 1% gel once-a-day vs clindamycin 1% solution twice-a-day, and to demonstrate its superiority vs its vehicle alone. A total of 592 subjects were included. After 12 weeks, a 65% reduction in inflammatory lesion count was observed with both active treatments. The gel was superior to its vehicle for total and inflammatory lesion reduction, Global Assessment of Improvement, and Global Severity Grade at final visit (all p < 0.01). No difference was found between the 2 active treatments for any of the evaluated criteria. Local tolerance in each active treatment group was slightly better with clindamycin gel (1.9% of subjects) relative to 3.1% in the topical solution group. In conclusion, the new water-based gel once-a-day formulation of clindamycin 1% is an effective, safe, and convenient alternative to the twice-a-day topical solution formulation in the treatment of acne vulgaris.

Multicenter randomized comparative double-blind controlled clinical trial of the safety and efficacy of zinc gluconate versus minocycline hydrochloride in the treatment of inflammatory acne vulgaris.

BACKGROUND: In addition to tetracyclines, zinc may constitute an alternative treatment in inflammatory lesions of acne. OBJECTIVE: To evaluate the place of zinc gluconate in relation to antibiotics in the treatment of acne vulgaris. METHODS: Zinc was compared to minocycline in a multicenter randomized double-blind trial. 332 patients received either 30 mg elemental zinc or 100 mg minocycline over 3 months. The primary endpoint was defined as the percentage of the clinical success rate on day 90 (i.e. more than 2/3 decrease in inflammatory lesions, i.e. papules and pustules). RESULTS: This clinical success rate was 31.2% for zinc and 63.4% for minocycline. Minocycline nevertheless showed a 9% superiority in action at 1 month and one of 17% at 3 months, with respect to the mean change in lesion count. Regarding safety, the majority of the adverse effects of zinc gluconate and of minocycline concerned the gastrointestinal system and were moderate (5 dropouts with zinc gluconate and 4 with minocycline). CONCLUSION: Minocycline and zinc gluconate are both effective in the treatment of inflammatory acne, but minocycline has a superior effect evaluated to be 17% in our study.

A low-salt medical water reduces irritancy of retinoic acid in facial acne.

Although effective medications are available for the treatment of acne, tolerance problems may preclude adequate treatment regimens such as topical retinoic acid, and reduce patient compliance. The present study was conducted to evaluate whether a medical water (Avène) in conjunction with retinoic acid may improve local tolerance in acne. A controlled, open, randomised, multicentric study was completed after 28 days of treatment in 69 acne patients, 34 applying a retinoic acid preparation alone, and 35 applying retinoic acid in association with the water spray used ad libitum. Topical retinoic acid treatment induced prominent signs of irritation in both groups. However, a statistically significant reduction between the two treatment groups could be demonstrated on scaling at all assessment visits (p< or =0.02, Wilcoxon test). No significant water effect on erythema, burning and itching was shown during the treatment period. The overall tolerance assessed by the investigator was significantly improved with the water (p = 0.04, Wilcoxon). Taken together, water with a low mineral content appears to be a promising adjunctive treatment for improving the tolerance of topical retinoids in acne.

A comparison of the efficacy and safety of lymecycline and minocycline in patients with moderately severe acne vulgaris.

A multicentre, randomised, double-blind and double-dummy study was conducted to compare the efficacy and safety of lymecycline (n = 71) with that of minocycline (n = 73) in 144 patients with moderately severe acne vulgaris. Patients with an acne score of 1-5 on the Leeds scale received oral lymecycline, 300 mg/day for 2 weeks, then 150 mg/day for 10 weeks or oral minocycline, 100 mg/day for 2 weeks then 100 mg every other day for 10 weeks. Inflammatory, non-inflammatory and total lesion counts were determined at baseline (week 0) and after 4, 8 and 12 weeks' treatment, and global efficacy and safety assessments were made by the patient and investigator at the end of the study. Both treatments were equally effective at reducing differential lesion counts and improving acne condition and severity, with no significant differences between treatments. Inflammatory lesions were reduced by 50.6% and 52.2% with lymecycline and minocycline, respectively, and non-inflammatory lesions by 40.6% and 32.2%. Acne severity was reduced by 42.4% with lymecycline and by 47.9% with minocycline. A total of 4.3% of lymecycline recipients and 4.1% of minocycline recipients experienced treatment-related adverse events, the majority of which were mild in nature. Lymecycline was as effective as minocycline for the treatment of moderately severe acne vulgaris. Both treatments were well tolerated, although there were slightly fewer adverse gastrointestinal and dermatological effects with lymecycline.

Systemic antibiotics for acne.

Antibiotic therapy for acne is very common. Antibiotics are frequently used in acne, either systemically or topically. Systemic antibiotics are indicated as treatment of moderate and quite severe acne or if acne is considered as very serious by the patient for psychological or social reasons. Results are very often excellent, but failure is possible; in this case using another treatment, especially isotretinoin, is necessary. A few antibiotics are useful: tetracyclines (tetracycline, doxycycline, minocycline, lymecycline), erythromycin, co-trimoxazole and trimethoprim. Their side effects are reviewed. During pregnancy the best antibiotic is erythromycin. For the nursing mother it is generally said that tetracyclines are contraindicated but the risks if they exist are certainly slight. The mechanism of action of systemic antibiotics for acne is not perfectly clear as it is not only antimicrobial: they diminish chemotaxis of polymorphonuclear leukocytes, modify the complement pathways and inhibit the polymorphonuclear leukocyte chemotactic factor and the lipase production in Propionibacterium acnes.

Evaluation of clinical efficacy and safety of adapalene 0.1% gel versus tretinoin 0.025% gel in the treatment of acne vulgaris, with particular reference to the onset of action and impact on quality of life.

A randomized, multicentre, investigator-masked study was conducted in 105 patients with mild to moderate acne vulgaris to compare the efficacy and safety of adapalene 0.1% gel with tretinoin 0.025% gel after three months of treatment, with particular emphasis on reduction in inflammatory lesion counts after one week of treatment and impact on quality of life. In terms of efficacy, adapalene gel was found to be superior to tretinoin gel after one week of treatment, with respect to reduction in inflammatory lesion counts (32% vs. 17%, respectively; P = 0.001), total lesion counts (28% vs. 22%, respectively; P = 0.042) and global severity grade (28% vs. 16%, respectively; P = 0.001). No significant difference between the two treatments was found after 12 weeks of treatment for any of these variables. Evaluation of facial skin tolerance parameters showed significant differences between the two treatments in favour of adapalene for dryness, erythema, immediate and persistent burning and pruritus for at least one time point. One patient in the adapalene group and three patients in the tretinoin group experienced medical events which lead to discontinuation of treatment (skin irritation; NS). Quality of life scores improved more rapidly in the adapalene group than in the tretinoin group, with significant differences (P < 0.05) appearing at week 1 for questions related to problems with partners, close friends or relatives and to skin symptoms. There was also a significantly greater improvement in social and leisure activity in the adapalene group at week 12. Adapalene 0.1% gel reduced inflammatory and total lesion counts more rapidly than tretinoin 0.025% gel, and was also better tolerated. These differences appear to result in an earlier and greater quality of life improvement for the patients receiving adapalene.

Clinical efficacy and safety comparison of adapalene gel and tretinoin gel in the treatment of acne vulgaris: Europe and U.S. multicenter trials.

BACKGROUND: Adapalene is a new chemical entity that exhibits tretinoin-like activities in the terminal differentiation process. OBJECTIVE: We evaluated a dose range effect of two concentrations of adapalene gel as acne treatment and compared adapalene 0.1% gel with tretinoin 0.025% gel in the treatment of acne patients in two large multicenter studies. METHODS: Multicenter, investigator-masked, parallel group studies including 89 acne patients in the dose range study and 591 patients in the concurrent controlled studies were conducted. RESULTS: Adapalene gel 0.1% was significantly more effective in treating acne lesions than 0.03% adapalene gel. Adapalene gel 0.1% was significantly more effective than 0.025% or tretinoin gel in one study and of the same effectiveness in the other study. Adapalene gel was always better tolerated than tretinoin gel. CONCLUSION: Adapalene 0.1% gel is a safe and effective treatment of acne vulgaris.

[Comparative study of the efficacy and tolerability of 0.1 and 0.03 p.100 adapalene gel and 0.025 p.100 tretinoin gel in the treatment of acne]. / Etude comparative de l'efficacité et de la tolérance de gels d'adapalène à 0.1 et 0.03 p. 100 et d'un gel de trétinoïne à 0.025 p. 100 dans le traitement de l'acné.

INTRODUCTION: Adapalene is a new chemical entity with retinoid activity. PATIENTS AND METHODS: 0.1 p. 100 adapalene gel (Différine gel), 0.03 p. 100 adapalene gel and a commercially available 0.025 p. 100 tretinoin gel (Aberel gel) were compared in 89 male and female patients with acne. RESULTS: Inflammatory, non inflammatory, total lesion counts, and the global facial acne grade regularly decreased as a function of time in the three treatment groups. No statistically or clinicaly significant differences were observed for these parameters between 0.1 p. 100 adapalene gel and 0.025 p. 100 tretinoin gel following a 12-week treatment. Conversely, both of these gels were significantly more effective than 0.03 p. 100 adapalene gel with regards to inflammatory and total lesion counts, and the global facial acne grade. The differences of efficacy seen between both adapalene gels demonstrate a dose-dependent activity of the drug in the topical treatment of acne. The three products induced retinoid-like skin irritation with significant differences in intensity in favour of adapalene for erythema, dryness, scaling and burning after application and in favour of tretinoin for persistent burning. No treatment-related medical events were reported and adapalene plasma levels were lower than 0.15 ng/ml (limit of detection of the analytical method). CONCLUSIONS: The topical treatment of acne with adapalene gels was found to be safe and effective, with a dose-related response. The efficacy of 0.1 p. 100 adapalene gel and of 0.025 p. 100 tretinoin gel are not different but skin tolerance of 0.1 p. 100 adapalene gel is superior.

Clinical evaluation of topical isotretinoin in the treatment of actinic keratoses.

BACKGROUND: Retinoids have been shown to improve the manifestations of skin photodamage, including actinic keratoses. OBJECTIVE: The efficacy and tolerability of isotretinoin 0.1% cream in the treatment of actinic keratoses were evaluated in a randomized, double-blind, placebo-controlled, parallel-group study. METHODS: One hundred patients were randomly assigned to treatment with 0.1% cream or vehicle twice daily for 24 weeks to the face, the scalp, and the upper extremities. Patients were assessed every 4 weeks by the investigators, who counted and recorded the number of lesions in each treatment area. The 93 patients who had at least one postbaseline assessment were included for efficacy analysis. Local tolerability was evaluated at each study visit. RESULTS: On the face, the reduction in number of actinic keratoses (mean +/- SEM) at the end of treatment was greater for patients treated with isotretinoin (3.9 +/- 0.6, i.e., 66% of patients with a reduction > 30%) than with placebo (1.7 +/- 0.5, i.e., 45% of patients with a reduction > 30%); this difference was statistically significant (p = 0.001). No significant drug effect was seen for lesions on the scalp or upper extremities. Mild to moderate local reactions with isotretinoin abated with reduced treatment frequency. CONCLUSION: Our results suggest that isotretinoin 0.1% cream cannot compete with more rapid treatments of actinic keratoses. However, its effect on facial lesions may be beneficial during long-term treatment of associated sun-damaged skin.

Studies of polymorphonuclear migration into psoriatic skin using a new in vivo method.

A new method, employing a skin-implanted cell trap already used to study chemotaxis in cancer patients, was applied to 35 healthy volunteers and 12 psoriatic patients. A dacron disk impregnated with 10 microliters of 4-6.10(6) live BCG suspension was implanted in the deep dermis. After 24 h the disk was removed, and five sections of each disk were counted for polymorphonuclear leukocytes (PMNs) and monocytes. Involved and uninvolved psoriatic skin showed a decrease of PMN migration into the disk as compared with controls. No difference could be demonstrated between involved and uninvolved skin. Mononuclear cell chemotaxis was the same in psoriasis as in controls. These results are in agreement with other in vivo data using mainly the skin chamber technique indicating a decrease of PMN chemotaxis in psoriatic skin at 24 h.

Radiation necrosis of the brain: time of onset and incidence related to total dose and fractionation of radiation.

Clinical deterioration during or after brain irradiation may be due to progression of neoplasm or radiation induced necrosis of the neoplasm and/or of normal brain tissues, or a combination of all. Eight patients with histologically documented radiation induced lesions of the brain are included in this study. The radiation therapy included the fractional schedule, group A, who received 280 to 300 rads daily, to a total dose of 4500 to 5000 rads and weekly exposure did not exceed 900 rads. Group B patients were exposed to 850 rads, daily dose on day 1, 3, 21 and 23 to a total dose of 3400 rads. The incidence of radiation induced lesions of brain was 3.4% in patients group A and 8.7% in group B patients (without statistical significance). The median time of onset of these lesions after completion of radiation therapy was significantly shorter in group B patients (8.5 months) as opposed to group A patients (21 months).