Abstract
ANTI ACNE SPOT CREAM IN CONTROLLING FACIAL ACNE : A PROSPECTIVE OPEN LABEL MULTICENTER SAFETY AND EFFICACY TRIAL.

Dr. Muhammed Majeed, Dr. Raju M. Rhee and Prachi S. Lad*

ABSTRACT

Background: Anti acne spot cream is recommended for treatment of mild to moderate facial acne vulgaris. The safety and efficacy of anti-acne spot cream was evaluated over a period of 60 days. Aim: To evaluate the safety and efficacy of anti-acne spot cream in patients with mild to moderate facial acne. Methods: Thirty six subjects with mild to moderate facial acne and between the age group of 18 to 50 years were enrolled in the study to receive anti-acne spot cream. The cream was to be applied twice a day on the acne affected area for 60 days. Subjects were instructed to apply the anti-acne formulation daily during the study duration irrespective of their visits to the clinic. Subjects visited the study site during initial Screening and Days 0, 15, 30, 45 and 60. Physical examination, Vitals and Adverse Events (if any) were recorded on all visits. Clinical determinations of disease severity was performed using IGA scale and non-inflammatory and inflammatory lesion counts during initial Screening, Days 0, 15, 30, 45 and Day 60 along with assessment of local cutaneous tolerability and safety. Quality of Life was assessed using Cardiff Acne Disability Index at Baseline and Final Visit. Standardized clinical photographs were captured at baseline, Day 45 and final visit (Day 60). Results: The Anti-acne spot cream showed statistically significant difference in all the efficacy parameters at different time points from baseline to end of the study. The percent change in inflammatory and non- inflammatory lesion count was found to be 63.8% and mean change was found to be statistically significant (p<0.0001) in total inflammatory and non- inflammatory lesion count as compared to baseline. The quality of life was assessed using Cardiff Acne Disability Index questionnaire. The mean change from day 0 in CADI score was found to be 5.4±3.1 and was statistically highly significant (p<0.0001) as compared to day 0. No adverse events were observed during the entire duration of the study. Conclusions: We conclude based on the results of the efficacy assessments, the anti-acne spot cream was very effective in treating facial acne. It has shown significant effect in reducing the lesion count without any side effects. Hence the formulation is an effective and safe treatment option in patients with facial acne.

Keywords: Acne, Investigator’s Global Assessment, Cardiff Acne Disability Index, Quality of Life.


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