Adapalene-Clindamycin Combination Gel Successfully Completes Patient Recruitment in Phase III Clinical Trial in China

BeijingNovember 22, 2019 /PRNewswire/ -- China Ophthalmology Focus Limited (“COPFL”) announced today that, following its earlier announcement in October 2019 regarding the completion of Phase II clinical studies of Cyclosporine A Ophthalmic Gel in China (ClinicalTrials.gov registration number: NCT03676335), its wholly-owned subsidiary, ZK Eye (Guangzhou) Pharmaceutical Co., Ltd. (“ZKO”), has successfully completed patient enrollment for the Phase III study of its Adapalene-Clindamycin Compound Gel in China on November 22, 2019.

Clinical Study of Adapalene-Clindamycin Combination Gel (clinicaltrials.gov Registration Number: NCT03615768) is a Phase III, multicenter, randomized, single-blind, parallel-group, active-controlled clinical study conducted in China. The objective of this study was to compare the efficacy and safety of Adapalene-Clindamycin Combination Gel versus Adapalene Gel alone and Clindamycin Gel alone in the treatment of moderate to severe acne vulgaris. It has been consistently reported that the combination of adapalene and clindamycin yields superior outcomes in the treatment of acne. This novel formulation combines the two agents into a single gel for once-daily application, thereby offering greater convenience.

The design of this Phase III clinical trial was developed in consultation with the Center for Drug Evaluation (CDE) following the successful completion of the Phase II study in 2017. The study involved 28 clinical trial centers and enrolled a total of 1,617 patients in China, including 95 adolescents aged 12 to 18 years. Patients were divided into three intervention groups, receiving either: i) once-daily nighttime application of a combination gel containing 0.1% adapalene and 1% clindamycin; ii) once-daily nighttime application of 0.1% adapalene gel; or iii) twice-daily application of 1% clindamycin phosphate gel. The treatment duration was 12 weeks, during which efficacy and safety parameters were assessed concurrently. The primary efficacy endpoints were the percent change from baseline in total lesion counts at the end of treatment (Day 85 ± 3 days) and the proportion of subjects in each group achieving a 2-grade reduction in the Investigator’s Global Assessment (IGA) score. The sample size was calculated to detect the superiority of the combination gel over the two single-agent components in terms of efficacy. Top-line data readouts were expected after the last patient was treated in early February 2020, with the New Drug Application anticipated to be submitted in the first half of 2020.

Dr. Li Xiaoyi, Chairman of ZKO, stated, “We are proud to have completed patient enrollment for the Phase III trial of the adapalene-clindamycin combination gel, as this represents the largest dermatological study conducted in China to date, with a total of 1,617 patients enrolled.” He added, “We believe that the combination of adapalene (a retinoic acid receptor [RAR] agonist) and clindamycin (an antibiotic) will be more effective in treating moderate-to-severe acne than conventional therapies. We eagerly anticipate receiving our top-line data early next year.”

On Adapalene-Clindamycin Combination Gel

Adapalene-Clindamycin Combination Gel is a patented product under development by ZKO for the treatment of moderate to severe acne vulgaris. Adapalene is a retinoic acid receptor (RAR) agonist that promotes skin cell turnover, while clindamycin is an antibiotic that inhibits bacterial protein synthesis. The combination of adapalene and clindamycin, which have distinct mechanisms of action, is more effective in treating acne than either ingredient used alone.