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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