To Evaluate the Efficacy and Safety of Minocycline Hydrochloride Foam in the Treatment of Moderate-to-severe Acne Vulgaris

NCT ID: NCT04960930

Last Updated: 2023-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 372 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-17
• Study Completion Date: 2022-10-14

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.

Conditions

Acne Vulgaris

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

FMX101

FMX101 4% minocycline foam

Group Type: EXPERIMENTAL

FMX101

Intervention Type: DRUG

topically once daily

Vehicle Foam

Vehicle Foam

Group Type: PLACEBO_COMPARATOR

FMX101

Intervention Type: DRUG

topically once daily

Interventions

FMX101

topically once daily

Intervention Type: DRUG

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.

• Minimum Eligible Age: 9 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cutia Therapeutics (Shanghai) Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Xuanwu Hospital Capital Medical University

Beijing, Beijing Municipality, China

Peking University Shougang Hospital

Beijing, Beijing Municipality, China

Peking University Third Hospital

Beijing, Beijing Municipality, China

China-Japan Friendship Hospital

Beijin, Beijin, China

Beijing Tsinghua Changgung Hospital

Beijin, Beijin, China

The Southwest Hospital Of Amu

Chongqing, Chongqing Municipality, China

The First Affiliated Hospital Of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, China

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Dermatology Hosptial of Southern Medical University

Yuexiu, Guangdong, China

The Second Hospital Of Hebei Medical University

Shijiazhuang, Hebei, 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

The First Hosptial of China Medical University

Shenyang, Liaoning, China

Shengjin Hospital of China Medical University

Shenyang, Liaoning, China

Qilu Hospital of Shandong University

Jinan, Shandong, China

The Affiliated Hosptial of Qingdao University

Qingdao, Shandong, China

Shanghai Medical College of Fudan University

Shanghai, Shanghai Municipality, China

Shanghai Skin Disease Hospital Skin Disease Hospital of Tongji University

Shanghai, Shanghai Municipality, 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 Municipality, China

Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital

Tianjing, Tianjing, China

Hangzhou Third People's Hospital

Hangzhou, Zhejiang, China

Sir Run Run Shaw Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

The Second Affiliated Hosptial Zhejiang University School Of Medicine

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

CU-10201-301

Identifier Type: -

Identifier Source: org_study_id