Facial skin revitalization with CPM®-HA20G: an effective and safe early intervention treatment.

BACKGROUND: Hyaluronic acid (HA) fillers are popular for the treatment of signs of facial skin aging. OBJECTIVE: The objective of this study was to confirm the performance and safety of a new cohesive polydensified matrix HA filler ([CPM®-HA20G, Belotero Revive®, lidocaine-free], Merz Pharmaceuticals GmbH, Frankfurt, Germany) for the treatment of early signs of facial skin aging by use of biophysical measurements as well as subject and investigator satisfaction. METHODS: Twenty-five healthy female subjects with signs of facial skin aging were enrolled in this open-label, rater-blinded, observational post-market clinical follow-up study, and received 20 micropuncture treatments of 50 µL CPM®-HA20G each into the lower cheek area at three injection visits 4 weeks apart. Objective biophysical assessments were conducted to demonstrate effects on viscoelastic properties of the skin, surface roughness, tone and radiance, and hydration, at baseline and at all follow-up visits up to 36 weeks. RESULTS: CPM®-HA20G significantly increased gross elasticity of the skin (at weeks 9 and 12), skin firmness (up to week 24), skin tone and radiance and skin hydration (all up to 36 weeks). Significant reduction of skin fatigue (up to 9 weeks), skin roughness (up to 28 weeks), and redness (up to 36 weeks) was also observed. Subjects and blinded investigator were highly satisfied with the treatment outcomes. The treating investigator reported a high level of satisfaction with the ease of injection and the clinical performance of the device. Moreover, data demonstrated a good safety profile of the device. CONCLUSION: CPM®-HA20G is considered to be an effective and safe HA injectable for skin revitalization in patients suffering from signs of skin aging and loss of skin elasticity. It seems to be a perfect early intervention approach in patients that do not need volumizing treatment and a combination approach in older patients with more pronounced aging.

Stabilized hyaluronic acid-based gel of non-animal origin for skin rejuvenation: face, hand, and décolletage.

BACKGROUND: Mid-dermal injection of stabilized hyaluronic acid (HA) is well established as a treatment to reduce the effects of skin aging. OBJECTIVE: To assess the efficacy and safety of a stabilized HA-based gel of non-animal origin manufactured using the patented NASHA® technology (Restylane® Vital Light, Q-Med AB, Uppsala, Sweden) administered using a pre-filled micropuncture injector device for rejuvenation of the skin. METHODS: Three treatment sessions 4 weeks apart were performed on one side of the face, the dorsum of one of the hands and one side of the décolletage, leaving the other side untreated. Skin quality was assessed via blinded live evaluation and subject satisfaction by questionnaire. Aesthetic change was evaluated independently by the subject and a blinded evaluator. Subjects were followed up to week 36. RESULTS: Thirty subjects aged 40-65 years were enrolled. Overall skin quality across all three treatment areas was judged to be improved on the treated side in over 80% of subjects throughout the study. Significant aesthetic improvements on the treated sides were observed at all visits, with the exception of the décolletage at week 36. CONCLUSIONS: This was the first study that used a micropuncture injector device for injection of NASHA gel, and reveals that this is a promising treatment option for rejuvenation of the skin.

Efficacy, safety, and patient satisfaction of a monophasic cohesive polydensified matrix versus a biphasic nonanimal stabilized hyaluronic acid filler after single injection in nasolabial folds.

BACKGROUND: Intradermal injection of hyaluronic acid (HA) is currently the criterion standard to reduce the appearance of nasolabial folds (NLF). OBJECTIVE: Effects of a monophasic HA filler using cohesive polydensified matrix (CPM) technology were compared with those of nonanimal stabilized HA (NASHA). MATERIALS AND METHODS: In a double-blind, half-side comparison, 20 subjects (ages 35-65, mean 52 ± 5.6) with symmetric NLF grade 3 to 4 were randomized to contralateral treatment with a monophasic polydensified filler (CPM) and a biphasic HA filler (NASHA). Efficacy was assessed at baseline and after 2, 24, and 48 weeks using a wrinkle severity rating scale (WSRS) for NLF, subject questionnaire, and biophysical in vivo methods. RESULTS: All subjects showed significant improvements with both fillers up to day 365. Subject questionnaires confirmed significantly less injection pain for the CPMHA, significantly greater patient satisfaction after 2 weeks with both fillers, and after 24 and 48 weeks significantly greater improvement with the CPMHA compared to baseline. WSRS and skin surface topography parameters improved significantly up to 48 weeks with both fillers. CONCLUSION: A single intradermal injection of a monophasic CPMHA and a biphasic NASHA filler showed significant improvements in WSRS and measured wrinkle depth up to 48 weeks for both fillers and significant differences in injection comfort and patient satisfaction in favor of CPMHA.

Hyperhidrosis plantaris - a randomized, half-side trial for efficacy and safety of an antiperspirant containing different concentrations of aluminium chloride.

BACKGROUND: Primary focal hyperhidrosis plantaris can cause impairment in social, physical, leisure and occupational activities. Topical treatment with aluminium chloride is the first-line treatment. The aim of this trial was to evaluate efficacy and safety of two different concentrations of aluminium chloride hexa-hydrate (12.5%, 30%) for 6 weeks. PATIENTS AND METHODS: 20 volunteers with hyperhidrosis plantaris were included. Efficacy was evaluated using a clinical rating scale of the hyperhidrosis level and qualitative assessments including Minor's (iodine-starch) test and a standardized sniff test. Furthermore a patient questionnaire and measurements of skin surface pH were done to evaluate the subjective assessments and side effects. RESULTS: The hyperhidrosis level significantly decreased in both concentrations. There were no differences in tolerability regarding the skin surface pH and the patient questionnaires. In addition the hidrotic areas decreased after application of both products and the sniff test improved. CONCLUSION: Topical application of an antiperspirant containing aluminium chloride reduced sweat production in plantar hyperhidrosis significantly. As both 12.5% and 30% were efficacious and safe, we would recommend 12.5% for outpatient treatment.

Effects of a three-session skin rejuvenation treatment using stabilized hyaluronic acid-based gel of non-animal origin on skin elasticity: a pilot study.

The purpose of this study was to evaluate in vivo the effects of micropuncture injections of stabilized hyaluronic acid-based gel of non-animal origin (NASHATM, Restylane Vital) on skin elasticity, a major aspect of skin ageing. Patients (n = 19) underwent a series of three treatment sessions, spaced 4 weeks apart, with NASHA injected into the lower facial cheeks. Using the suction principle, 12 parameters describing the viscoelastic properties of the skin were assessed, before each treatment session and at follow-up visits 4 and 16 weeks after the last treatment. Treatment with NASHA significantly increased skin firmness and improved its viscoelastic recovery capacities. The most significant differences from baseline were noted at the end of the study. The changes observed in this study may underlie some of the cosmetic improvements noted after treatment with NASHA.

Effects of an oral contraceptive containing chlormadinone and ethinylestradiol on acne-prone skin of women of different age groups: an open-label, single-centre, phase IV study.

BACKGROUND AND OBJECTIVE: Acne-prone skin, a common skin condition not only in adolescents but also in adults, can significantly influence the affected individual's quality of life. The aim of this open-label, prospective, single-centre, phase IV study was to investigate the effects of an oral contraceptive containing chlormadinone 2 mg and ethinylestradiol 0.03 mg (Belara) on the physiology of acne-prone facial skin in healthy women aged 18-37 years. METHODS: Forty-four Caucasian women requesting hormonal contraception divided into two age groups (group A: 18-27 years; group B: 28-37 years) were treated with chlormadinone/ethinylestradiol for six menstrual cycles. During each treatment phase, each subject took one tablet per day for 21 consecutive days, followed by a 7-day pill-free interval. Medication was commenced on the first day of menses. Changes in skin parameters were evaluated in terms of the clinical sum score (the primary outcome variable, calculated from the number of comedones, the number of papules/papulopustules, and the sebum secretion state), the evaluation of the pore size using standardized photography, and a range of biophysical in vivo measurements, assessed at baseline, after 12 weeks and after 24 weeks. RESULTS: In both age groups, facial skin condition as quantified by the clinical sum score improved significantly after three and six treatment cycles, with reduced numbers of acne lesions (comedones and papules/papulopustules) and a reduction in seborrhoea. Moreover, there was a statistically significant decrease in pore size. Biophysical evaluations confirmed favourable effects of the medication on diverse skin parameters. Skin surface pH remained within the normal physiological range and there was an improvement in epidermal barrier function (as manifested by decreased transepidermal water loss from the skin of the forehead). Stratum corneum hydration increased in both age groups and the lipid content of the skin surface on the forehead decreased significantly after three treatment cycles in subjects aged 28-37 years. Ultrasound measurements verified that there was no retention of water within the dermis. There was no difference between the two age groups. CONCLUSION: For the first time, improvements in several facial skin parameters during treatment with a combined oral contraceptive (chlormadinone/ethinyl-estradiol) were quantified by biophysical methods and a clinical sum score. The highly statistically significant improvements in clinical findings and various biophysical skin parameters observed in this study suggest that the antiandrogenic oral contraceptive chlormadinone/ethinylestradiol may be a major therapy option in women with acne-prone skin who request hormonal contraception.

Rejuvenating influence of a stabilized hyaluronic acid-based gel of nonanimal origin on facial skin aging.

BACKGROUND: Skin changes associated with aging, such as loss of elasticity and turgor, can have a negative psychosocial impact. Current treatment options aimed at restoring elasticity are often ineffective or hampered by a poor risk/benefit ratio. OBJECTIVE: Clinical observations and biophysical measurements were used to assess the effect of middermal placement of stabilized hyaluronic acid-based gel of nonanimal origin (NASHA, Restylane, Vital, Q-Med) on the appearance and elasticity of facial skin. METHODS AND MATERIALS: In this pilot study, 19 female patients underwent a series of three treatment sessions, spaced 4 weeks apart, with NASHA injected into the lower cheeks. Elasticity, skin surface roughness, dermal thickness, and density were evaluated at each treatment session and at 4 and 12 weeks after the last treatment session. Patient satisfaction was assessed, and photographs were taken at each visit. RESULTS: During the course of the study, skin elasticity and surface roughness improved significantly. Patient feedback was extremely positive. CONCLUSION: Micropuncture placement of NASHA can exert a rejuvenating effect on facial skin.

Gender difference of in vivo skin surface pH in the axilla and the effect of a standardized washing procedure with tap water.

The purpose of our study was to evaluate the axillary skin surface pH and explore potential gender-related differences together with the influence of a washing procedure in healthy subjects. After a run-in period, the skin surface pH was measured in vivo in 10 men and 10 women under standardized conditions in three distinct locations of each axilla (at baseline and up to 6 h after washing). Potential interfering influences were thoroughly excluded. Our study revealed a statistically significant difference in axillary skin surface pH between men and women with more acidic values in females (p < or = 0.001). The baseline axillary pH before washing was 6.58 +/- 0.63 (right) and 6.67 +/- 0.65 (left) in men compared to 5.8 +/- 0.53 (right) and 5.94 +/- 0.62 (left) in women. The difference between the right and left arm-pit was not statistically significant (p > 0.05) in any group. After standardized washing procedures with pure tap water, the mean axillary pH decreased significantly in women at all measurement times [lowest value 60 min after washing: 5.51 +/- 0.7 (right) and 5.64 +/- 0.7 (left)], while it slightly increased in men [highest value 240 min after washing: 6.7 +/- 0.59 (right) and 6.78 +/- 0.69 (left)]. In summary, there is a gender difference in axillary skin surface pH. Washing with water further increased the difference between male and female pH values.