Fluorouracil cream 0.5% for actinic keratoses on multiple body sites: an 18-month open-label study.

This prospective 18-month, open-label, multicenter study assessed the long-term safety and efficacy of fluorouracil cream 0.5% in 277 participants with multiple actinic keratoses (AKs) on the face/anterior scalp and other body sites. Two treatment/observation cycles were separated by 12 months. During treatment cycle 1 (TC1), all participants were treated with fluorouracil cream 0.5% for 4 weeks with 4-week follow-up. Twelve months later, all participants were assessed for treatment cycle 2 (TC2); participants with face/anterior scalp AKs (N = 98) were re-treated with fluorouracil cream 0.5% for 4 weeks with 4-week follow-up. Only 4 participants (7.4%) experienced a treatment-related adverse event (AE) that was not an application site reaction or eye irritation. No unexpected AEs were reported; most were mild or moderate. After TC1 (week 8), the number of AK lesions was significantly reduced on the face/anterior scalp and all other treated body sites (P < .0001). Clearance rates were 30.5% (hands), 39.8% (face/anterior scalp), and 79.1% (lips). After TC2 (week 60), face/anterior scalp AKs were significantly reduced (P < .0001) and the clearance rate was 33.3%. This study indicates that fluorouracil cream 0.5% with a patented microsponge delivery system was well-tolerated and effective in treating and preventing recurrence of AK lesions up to 18 months after initial treatment.

Comparative irritation potential of two combination acne products: a randomized controlled, subject- and evaluator-blind, comparative study in healthy volunteers.

BACKGROUND: Two topical 1% clindamycin/5% benzoyl peroxide combination products (BenzaClin [Dermik Laboratories, Inc., Bridgewater, NJ, USA] and Duac [Stiefel Laboratories, Coral Gables, FL, USA]) are commonly used in the treatment of mild-to-moderate acne vulgaris. One adverse event reported with their use is local skin irritation. OBJECTIVE: The primary aim of this study was to compare the irritation potential of BenzaClin and Duac using a cumulative irritant patch test on healthy human skin. METHODS: A randomized controlled, subject- and evaluator-blinded design was used to compare the cumulative irritation potential of BenzaClin, Duac, a positive control (0.2% sodium laurilsulfate [SLS]), and a negative control (white petrolatum) in healthy volunteers at a single US research study center. Forty subjects were enrolled and 37 completed the study. Most subjects were women (83%) and Caucasian (68%), and the mean age was 47 years. The 21-day cumulative irritation patch test was used to measure the irritation potential of the products applied under occlusive conditions. Evaluation of dermal reactions to the four products was assessed visually using an ordinal scoring system at the time of removal of each patch. The four patches were applied once daily over 21 days, excluding Saturdays and Sundays, resulting in a total of 15 applications. The primary endpoint, determined prior to data collection, was mean cumulative irritation score at the end of the study on day 22. RESULTS: At the end of the study, the mean cumulative irritation scores were not significantly different between BenzaClin and Duac (1.39 vs 1.36, respectively; p = 0.668). Both BenzaClin and Duac were significantly more irritating than white petrolatum and significantly less irritating than SLS (both p < 0.001). Based on mean cumulative irritation score, BenzaClin and Duac were classified as moderately irritating, SLS as highly irritating, and white petrolatum as not irritating. CONCLUSION: BenzaClin and Duac show similar propensity to cause moderate irritation compared with SLS and white petrolatum when applied to the skin of healthy subjects under occlusive patch conditions.

One-week treatment with once-daily fluorouracil cream 0.5% in participants with actinic keratoses.

Actinic keratoses (AKs) are common in fair-skinned individuals with a history of chronic and excessive sun exposure and may progress to squamous cell carcinoma (SCC). Topical fluorouracil is an effective therapeutic option for patients with AKs, but it is associated with substantial skin irritation. The efficacy and tolerability of 1-week treatment using microsponge-based fluorouracil cream 0.5% were analyzed in 356 participants with AK lesions. One-week treatment with once-daily fluorouracil cream 0.5% was significantly more effective than vehicle control in reducing AK lesions and in achieving complete clearance (P<.001). No serious treatment-related adverse events occurred. The most frequent treatment-related adverse events were facial and eye irritations, which were predominantly mild to moderate in severity. No participants in the fluorouracil cream 0.5% treatment group discontinued the study because of treatment-related adverse events. One-week treatment with once-daily fluorouracil cream 0.5% is an effective well-tolerated therapy for AKs. Using this short treatment duration period in combination with cryosurgery may prove beneficial in clinical practice. Extending treatment for up to 4 weeks will further improve AK lesion clearance rates.

Pilot investigation of the hydrating effects of topical acne medications.

Topical therapies are effective in managing acne vulgaris but are associated with local adverse effects such as irritation and dryness. This 4-week pilot study compared skin hydration in 36 healthy adult women randomized to treatment with 1 of 4 topical therapies: 2 different (jar and tube) clindamycin 1%/benzoyl peroxide 5% gels, sodium sulfacetamide 10% lotion, or over-the-counter (OTC) moisturizing cream. Subjects treated with OTC moisturizer or sodium sulfacetamide exhibited decreased water loss, increased water retention, similar or improved levels of skin hydration, and decreased desorption rates. In contrast, subjects treated with jar or tube clindamycin/benzoyl peroxide had increased water loss, decreased water retention, decreased hydration, and increased desorption rates. Skin dryness decreased slightly in the moisturizer group. No serious adverse events occurred. Overall, the OTC moisturizer had the best skin hydration profile. Sodium sulfacetamide demonstrated some moisturizing characteristics, and no clinically relevant differences were noted between jar and tube clindamycin/benzoyl peroxide gels.

Comparison of clindamycin/benzoyl peroxide, tretinoin plus clindamycin, and the combination of clindamycin/benzoyl peroxide and tretinoin plus clindamycin in the treatment of acne vulgaris: a randomized, blinded study.

In the treatment of mild to moderate acne vulgaris, the combination of an antibiotic and benzoyl peroxide provides enhanced efficacy over the individual agents, with the potential to decrease the emergence of resistant strains of P. acnes. To evaluate treatment regimens combining the daily use of a clindamycin/benzoyl peroxide gel, a tretinoin gel, and a clindamycin gel, the current randomized, evaluator-blind study was conducted. Results demonstrate that once-daily administration of clindamycin/benzoyl peroxide gel (combination formulation) was as effective as clindamycin/benzoyl peroxide gel + tretinoin gel + clindamycin gel. Both of these regimens provided greater efficacy than tretinoin + clindamycin. Treatment with clindamycin/benzoyl peroxide demonstrated a significant benefit over other treatments at Week 2, highlighting its rapid onset of action. All regimens were safe and generally well tolerated, with less severe peeling seen in patients who received clindamycin/benzoyl peroxide. In conclusion, the regimens that included clindamycin/benzoyl peroxide were more effective than tretinoin + clindamycin in the treatment of acne vulgaris, with no clinical advantage of adding tretinoin + clindamycin to once-daily clindamycin/benzoyl peroxide treatment.

Validation of a photonumeric wrinkle assessment scale for assessing nasolabial fold wrinkles.

BACKGROUND: Reliable clinical assessment tools are needed to evaluate the effects of injectable devices and fillers. This study was designed to validate a new photonumeric wrinkle assessment scale using standardized photographic methodology to obtain reference photographs. METHODS: Multiple photographs (test set) from approximately 78 volunteer subjects with varying degrees of severity of the left/right nasolabial fold wrinkles were examined. Photographs of 18 subjects representing the full spectrum of nasolabial fold wrinkle severity were selected from the test set by a study team of three independent physicians and were classified using a six-point scale (0 = no wrinkles; 5 = very deep wrinkle, redundant fold). One representative photograph was identified by study team consensus for each of the six scale points. Photographs were randomly arranged in booklets for a second, independent, group of five physician raters to grade both left/right nasolabial fold wrinkles twice over a 2-week interval. The scale was considered valid if interevaluator reliability, as measured by intraclass correlation coefficient, was greater than or equal to 80 percent. RESULTS: Intrarater reliability was significant (p < 0.001) for all five physicians and overall, with Pearson correlation coefficients greater than 92 percent in all cases. The overall weighted kappa coefficient for intrarater reliability for all five raters was 0.598 (range, 0.433 to 0.684). The overall interrater reliability kappa value was 0.525, and a high degree of interrater reliability was observed at week 1 and week 2 time points (intraclass correlation coefficient = 0.890 and 0.880, p < 0.001 for both), validating the new wrinkle assessment scale. CONCLUSION: This study validates the new wrinkle assessment scale, which provides a reliable clinical tool for use in nasolabial fold wrinkle evaluation.

Fluorouracil cream 0.5% for the treatment of actinic keratoses on the face and anterior scalp: interim results of an 18-month open-label study.

OBJECTIVE: This study further assessed the long-term safety and efficacy of fluorouracil cream 0.5% in patients with multiple actinic keratosis (AK) on the face/anterior scalp and other body sites. DESIGN/SETTING: This 18-month, prospective, open-label, multicenter study comprised two treatment cycles separated by 12 months. Cycle 1 included treatment of AK lesions on the face, anterior scalp, posterior scalp, ears, neck, lips, arms, and/or hands. Once-daily fluorouracil cream 0.5% was applied for four weeks as tolerated, followed by four weeks of follow-up in each treatment cycle. PARTICIPANTS: Adults (N=277) with five or more visible and/or palpable AK lesions on the face/anterior scalp and five or more lesions on the posterior scalp, ears, neck, lips, arms, and/or hands were enrolled. MEASUREMENTS: Main outcome measures included adverse events (AEs) and reduction/clearance of AK lesions on the face/anterior scalp after four weeks of treatment. RESULTS: RESULTS for treatment of AK lesions on the face/anterior scalp for Cycle 1 are reported. All 277 patients were treated during Cycle 1. Besides anticipated application-site reactions (67.9% and 19.1% of patients experiencing mild-to-moderate and severe events, respectively) and eye irritation, overall incidence of treatment-emergent AEs was low. No individual AE appeared in greater than four percent of patients. At the end of Cycle 1, significant reductions were noted in lesion counts on the face/anterior scalp (84.8%; P<0.0001). Clearance rate for lesions on the face and anterior scalp was 39.8 percent at eight weeks. CONCLUSION: RESULTS indicate that fluorouracil cream 0.5% is safe and effective for patients with multiple AK lesions on the face/anterior scalp.

Double-blind, randomized, vehicle-controlled clinical trial of once-daily benzoyl peroxide/clindamycin topical gel in the treatment of patients with moderate to severe rosacea.

BACKGROUND: Systemic antibiotics such as tetracycline are well accepted as effective in treating the inflammatory papular/pustular phase of rosacea but may be associated with systemic side-effects. Few controlled data on the use of topical antibiotics in rosacea are available. OBJECTIVE: We evaluated the efficacy and tolerability of a fixed combination of 5% benzoyl peroxide and 1% clindamycin in a topical gel for the treatment of rosacea. Methods This was a 12-week, double-blind, vehicle-controlled, randomized, prospective, parallel-group study in 53 patients with moderate to severe rosacea. RESULTS: The mean percentage reduction in papules and pustules from baseline to the end of treatment was 71.3% in the benzoyl peroxide/clindamycin group (n = 26) and 19.3% in the vehicle group (n = 26; P = 0.0056). A significant (P = 0.0141) difference in favor of benzoyl peroxide/clindamycin was evident by the third week of treatment. Severity scores for erythema, papules/pustules, and flushing/blushing decreased more with benzoyl peroxide/clindamycin than with vehicle. Overall rosacea severity, Physician Global Assessment, and Patient's Global Assessment at the end of treatment were all significantly improved with benzoyl peroxide/clindamycin compared with vehicle (P = 0.0101, 0.0026, and 0.0002, respectively). Application site reactions were reported in four patients (14.8%) in the benzoyl peroxide/clindamycin group. CONCLUSION: A once-daily topical application of a combination of 5% benzoyl peroxide and 1% clindamycin is effective and well tolerated in patients with moderate to severe rosacea.