To Evaluate the Efficacy and Safety of Minocycline Hydrochloride Foam in the Treatment of Moderate-to-severe Acne Vulgaris
- Registration Number
- NCT04960930
- Lead Sponsor
- Cutia Therapeutics (Shanghai) Co., Ltd
- Brief Summary
This is a randomized, multicenter, double-blind, vehicle-controlled, 2-arm study to evaluate the safety and efficacy in 12 weeks of FMX101 minocycline foam, 4%, compared to vehicle, in the treatment of subjects with moderate to severe facial acne vulgaris.
- Detailed Description
Qualified subjects will be randomized to receive 1 of the following 2 treatments:
* FMX101 4% minocycline foam
* Vehicle foam
Subjects with qualifying lesion counts and Investigator's Global Assessments (IGA) of acne severity scores and will be assigned to 1 of 2 treatments according to the randomization schedule. Subjects will apply the assigned study drug topically once daily for 12 weeks as directed. Subjects will be advised to apply the study drug at approximately the same time each day, preferably in the evening at bedtime. Both the Investigator and subject will be blinded to the study drug identity.
Subjects will return for visits at Weeks 1, 2, 4, 6, 8, and 12. At the discretion of the clinic staff, for the convenience of subjects or clinic staff, visits can be scheduled to occur 2 days before or after the nominal schedule date for the Weeks 1, 2, 4, 8 and 12 visits. Efficacy evaluations (acne lesion counts and IGAs) will be performed at each visit during the study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 372
-
Has completed and signed an appropriately administered Informed Consent Form (ICF) prior to any study-related procedures. Subjects less than 18 years of age (or as required by state law) must sign an Assent Form for the study and a parent or legal guardian must sign the ICF.
-
Has facial acne vulgaris with:
- 20 to 50 inflammatory lesions (papules, pustules, and nodules)
- 25 to 100 non-inflammatory lesions (open and closed comedones)
- No more than 2 nodules on the face
- IGA score of moderate (3) to severe (4)
-
Willing to use only the supplied non-medicated cleanser (Cetaphil Gentle Skin Cleanser) and to refrain from use of any other acne medication, medicated cleanser, excessive sun exposure, and tanning booths for the duration of the study.
- Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne), or any dermatological condition of the face or facial hair (eg, beard, sideburns, mustache) that could interfere with the clinical evaluations.
- Sunburn on the face.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description FMX101 FMX101 FMX101 4% minocycline foam Vehicle Foam FMX101 Vehicle Foam
- Primary Outcome Measures
Name Time Method ILC Week12 The efficacy assessments will inflammation lesion counts at week12
- Secondary Outcome Measures
Name Time Method nILC week 12 The efficacy assessments will non-inflammation lesion counts at baseline and week12
ILC week4 week 4 The Absolute Change From Baseline in the Inflammatory Lesion Count at Week 4
ILC week8 week 8 The Absolute Change From Baseline in the Inflammatory Lesion Count at Week 8
Investigator Global Assessment (IGA) week4 Week 4 IGA Treatment Success at Week 4 IGA Scale for Acne Vulgaris for study is 0-5, score 0 is clear and normal, and score 5 is very severe.
Investigator Global Assessment (IGA) week8 Week 8 IGA Treatment Success at Week 8 IGA Scale for Acne Vulgaris for study is 0-5, score 0 is clear and normal, and score 5 is very severe.
Investigator Global Assessment (IGA) week 12 Severity of acne vulgaris assessed by Investigator Global Assessment (IGA) IGA Scale for Acne Vulgaris for study is 0-5, score 0 is clear and normal, and score 5 is very severe.
Trial Locations
- Locations (29)
Beijing Friendship Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
China-Japan Friendship Hospital
🇨🇳Beijin, Beijin, China
Dermatology Hosptial of Southern Medical University
🇨🇳Yuexiu, Guangdong, China
The Second Hospital Of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
The First Hosptial of China Medical University
🇨🇳Shenyang, Liaoning, China
The Affiliated Hosptial of Qingdao University
🇨🇳Qingdao, Shandong, China
Shanghai Skin Disease Hospital Skin Disease Hospital of Tongji University
🇨🇳Shanghai, Shanghai, China
Qilu Hospital of Shandong University
🇨🇳Jinan, Shandong, China
Peking University Shougang Hospital
🇨🇳Beijing, Beijing, China
Xuanwu Hospital Capital Medical University
🇨🇳Beijing, Beijing, China
The Southwest Hospital Of Amu
🇨🇳Chongqing, Chongqing, China
The First Affiliated Hospital Of Chongqing Medical University
🇨🇳Chongqing, Chongqing, China
The Second Affiliated Hospital of Guangzhou Medical University
🇨🇳Guangzhou, Guangdong, China
The Third Xiangya Hospital Of Central South University
🇨🇳Changsha, Hunan, China
Institute of Dermatology Chinese Academy of Medical Sciences
🇨🇳Nanjin, Jiangsu, China
Wuxi People's Hospital
🇨🇳Wuxi, Jiangsu, China
The First Bethune Hosptial of Jilin University
🇨🇳Changchun, Jiling, China
Shengjin Hospital of China Medical University
🇨🇳Shenyang, Liaoning, China
Shanghai Medical College of Fudan University
🇨🇳Shanghai, Shanghai, China
The Second Affiliated Hospital of Xi'an Jiaotong University
🇨🇳Xi'an, Shanxi, China
West China Hospital Sichuan University
🇨🇳Chengdu, Sichuan, China
Tianjin Medical University General Hospital
🇨🇳Tianjin, Tianjin, China
Hangzhou Third People's Hospital
🇨🇳Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
Peking University Third Hospital
🇨🇳Beijing, Beijing, China
Beijing Tsinghua Changgung Hospital
🇨🇳Beijin, Beijin, China
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
🇨🇳Guangzhou, Guangdong, China
Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
🇨🇳Tianjing, Tianjing, China
The Second Affiliated Hosptial Zhejiang University School Of Medicine
🇨🇳Hangzhou, Zhejiang, China