Evaluation of Efficacy and Safety of AHPL/AYCAP/0413 Capsule and AHPL/ AYTOP/0213 Cream in Patients Suffering from Acne Vulgaris

Abstract

Background: Available treatments for acne vulgaris are associated with various adverse effects, which necessitate patients to opt for alternative treatment options. Objectives: To evaluate efficacy and safety of AHPL/AYCAP/0413 capsule and AHPL/AYTOP/0213 cream in subjects suffering from Acne Vulgaris. Method: A total of 62 subjects completed the study. Subjects were advised to take 2 capsules of AHPL/AYCAP/0413 twice daily orally after meals with water and apply AHPL/AYTOP/0213 cream all over the face twice a day for two months or complete resolution of acne whichever was earlier. The primary objective was to assess changes in total number of inflammatory acne lesions on face. Secondary objectives were to assess changes in total numbers of noninflammatory acne lesions, total lesion count (inflammatory and non-inflammatory), acne severity, acne scarring, signs and symptoms, skin lightening effect, post acne dark spots, adverse events and laboratory investigations. Results: The mean inflammatory acne lesion count reduced significantly from 7.94 ± 5.91 (baseline visit) to 1.89 ± 3.06 (p=0.001) at the end of treatment. Significant reduction in total numbers of non-inflammatory acne lesions, total lesion count, acne severity and signs and symptoms of acne were observed at the end of treatment. Also improvement in skin colour, severity of post acne dark spot and reduction in numbers of post acne dark spots were observed at the end of treatment. Laboratory parameters were within normal limits both at pre and post treatment. Conclusion: AHPL/AYCAP/0413 capsule and AHPL/AYTOP/0213 cream is safe and significantly effective for treatment of acne vulgaris.