Clinical trial NCT04960930: To Evaluate the Efficacy and Safety of Minocycline Hydrochloride Foam in the Treatment of Moderate-to-severe Acne Vulgaris
Official title: A Phase 3, Multi-center, Randomized, Double-Blind, Vehicle-controlled Study to Evaluate the Efficacy and Safety of Topical Administration of Minocycline Hydrochloride Foam (4%) in the Treatment of Moderate-to-Severe Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acne Vulgaris
Lead sponsor: Cutia Therapeutics (Shanghai) Co., Ltd
Sponsor class: INDUSTRY
First posted: 2021-07-14
Enrollment: 372
Sex: ALL
Minimum age (years): 9
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Drug: FMX101 FMX101, 4% minocycline foam

Drug: Vehicle Foam Vehicle Foam
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. 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)
3. 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.

Exclusion Criteria:

1. 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.
2. Sunburn on the face.

Primary outcomes:
measure: ILC
timeFrame: Week12
Secondary outcomes:
measure: Investigator Global Assessment (IGA)
timeFrame: week 12
measure: nILC
timeFrame: week 12
measure: ILC week4
timeFrame: week 4
measure: ILC week8
timeFrame: week 8
measure: Investigator Global Assessment (IGA) week4
timeFrame: Week 4
measure: Investigator Global Assessment (IGA) week8
timeFrame: Week 8
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Xuanwu Hospital Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Peking University Shougang Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Beijin
country: China
facility: China-Japan Friendship Hospital
state: Beijin
city: Beijin
country: China
facility: Beijing Tsinghua Changgung Hospital
state: Beijin
city: Chongqing
country: China
facility: The Southwest Hospital Of Amu
state: Chongqing
city: Chongqing
country: China
facility: The First Affiliated Hospital Of Chongqing Medical University
state: Chongqing
city: Guangzhou
country: China
facility: Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
state: Guangdong
city: Guangzhou
country: China
facility: The Second Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Yuexiu
country: China
facility: Dermatology Hosptial of Southern Medical University
state: Guangdong
city: Shijiazhuang
country: China
facility: The Second Hospital Of Hebei Medical University
state: Hebei
city: Changsha
country: China
facility: The Third Xiangya Hospital Of Central South University
state: Hunan
city: Nanjin
country: China
facility: Institute of Dermatology Chinese Academy of Medical Sciences
state: Jiangsu
city: Wuxi
country: China
facility: Wuxi People's Hospital
state: Jiangsu
city: Changchun
country: China
facility: The First Bethune Hosptial of Jilin University
state: Jiling
city: Shenyang
country: China
facility: The First Hosptial of China Medical University
state: Liaoning
city: Shenyang
country: China
facility: Shengjin Hospital of China Medical University
state: Liaoning
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Qingdao
country: China
facility: The Affiliated Hosptial of Qingdao University
state: Shandong
city: Shanghai
country: China
facility: Shanghai Medical College of Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Skin Disease Hospital Skin Disease Hospital of Tongji University
state: Shanghai
city: Xi'an
country: China
facility: The Second Affiliated Hospital of Xi'an Jiaotong University
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital Sichuan University
state: Sichuan
city: Tianjing
country: China
facility: Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
state: Tianjing
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
city: Hangzhou
country: China
facility: Hangzhou Third People's Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: The Second Affiliated Hosptial Zhejiang University School Of Medicine
state: Zhejiang
Study officials:
References: