To Evaluate the Efficacy and Safety of Minocycline Hydrochloride Foam in the Treatment of Moderate-to-severe Acne Vulgaris
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
1 other identifier
interventional
372
1 country
29
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Sep 2021
Shorter than P25 for phase_3
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 9, 2021
CompletedFirst Posted
Study publicly available on registry
July 14, 2021
CompletedStudy Start
First participant enrolled
September 17, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 27, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 14, 2022
CompletedSeptember 28, 2023
February 1, 2023
1 year
July 9, 2021
September 26, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
ILC
The efficacy assessments will inflammation lesion counts at week12
Week12
Secondary Outcomes (6)
Investigator Global Assessment (IGA)
week 12
nILC
week 12
ILC week4
week 4
ILC week8
week 8
Investigator Global Assessment (IGA) week4
Week 4
- +1 more secondary outcomes
Study Arms (2)
FMX101
EXPERIMENTALFMX101 4% minocycline foam
Vehicle Foam
PLACEBO COMPARATORVehicle Foam
Interventions
Eligibility Criteria
You may qualify if:
- 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:
- to 50 inflammatory lesions (papules, pustules, and nodules)
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (29)
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050, China
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, 100053, China
Peking University Shougang Hospital
Beijing, Beijing Municipality, 100144, China
Peking University Third Hospital
Beijing, Beijing Municipality, 100191, China
China-Japan Friendship Hospital
Beijin, Beijin, 100029, China
Beijing Tsinghua Changgung Hospital
Beijin, Beijin, 102218, China
The Southwest Hospital Of Amu
Chongqing, Chongqing Municipality, 400038, China
The First Affiliated Hospital Of Chongqing Medical University
Chongqing, Chongqing Municipality, 400042, China
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510120, China
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510260, China
Dermatology Hosptial of Southern Medical University
Yuexiu, Guangdong, 510091, China
The Second Hospital Of Hebei Medical University
Shijiazhuang, Hebei, 050004, China
The Third Xiangya Hospital Of Central South University
Changsha, Hunan, 410013, China
Institute of Dermatology Chinese Academy of Medical Sciences
Nanjin, Jiangsu, 210042, China
Wuxi People's Hospital
Wuxi, Jiangsu, 214023, China
The First Bethune Hosptial of Jilin University
Changchun, Jiling, 130061, China
The First Hosptial of China Medical University
Shenyang, Liaoning, 110001, China
Shengjin Hospital of China Medical University
Shenyang, Liaoning, 110004, China
Qilu Hospital of Shandong University
Jinan, Shandong, 250063, China
The Affiliated Hosptial of Qingdao University
Qingdao, Shandong, 266003, China
Shanghai Medical College of Fudan University
Shanghai, Shanghai Municipality, 200040, China
Shanghai Skin Disease Hospital Skin Disease Hospital of Tongji University
Shanghai, Shanghai Municipality, 200050, China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, 710004, China
West China Hospital Sichuan University
Chengdu, Sichuan, 610044, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052, China
Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
Tianjing, Tianjing, 300120, China
Hangzhou Third People's Hospital
Hangzhou, Zhejiang, 310009, China
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310020, China
The Second Affiliated Hosptial Zhejiang University School Of Medicine
Hangzhou, Zhejiang, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 9, 2021
First Posted
July 14, 2021
Study Start
September 17, 2021
Primary Completion
September 27, 2022
Study Completion
October 14, 2022
Last Updated
September 28, 2023
Record last verified: 2023-02