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

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.

Study Overview

• Status: Completed
• Conditions: Acne Vulgaris
• Intervention / Treatment: Drug: FMX101

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.

• Study Type: Interventional
• Enrollment (Actual): 372
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijin
    • Beijin, Beijin, China, 100029
      • China-Japan Friendship Hospital
    • Beijin, Beijin, China, 102218
      • Beijing Tsinghua Changgung Hospital
  • Beijing
    • Beijing, Beijing, China, 100191
      • Peking University Third Hospital
    • Beijing, Beijing, China, 100050
      • Beijing Friendship Hospital, Capital Medical University
    • Beijing, Beijing, China, 100053
      • Xuanwu Hospital Capital Medical University
    • Beijing, Beijing, China, 100144
      • Peking University Shougang Hospital
  • Chongqing
    • Chongqing, Chongqing, China, 400042
      • The First Affiliated Hospital of Chongqing Medical University
    • Chongqing, Chongqing, China, 400038
      • The Southwest hospital of AMU
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
    • Guangzhou, Guangdong, China, 510260
      • The Second Affiliated Hospital of Guangzhou Medical University
    • Yuexiu, Guangdong, China, 510091
      • Dermatology Hosptial of Southern Medical University
  • Hebei
    • Shijiazhuang, Hebei, China, 050004
      • The Second Hospital of Hebei Medical University
  • Hunan
    • Changsha, Hunan, China, 410013
      • The Third Xiangya Hospital of Central South University
  • Jiangsu
    • Nanjin, Jiangsu, China, 210042
      • Institute of Dermatology Chinese Academy of Medical Sciences
    • Wuxi, Jiangsu, China, 214023
      • Wuxi People's Hospital
  • Jiling
    • Changchun, Jiling, China, 130061
      • The First Bethune Hosptial of Jilin University
  • Liaoning
    • Shenyang, Liaoning, China, 110001
      • The First Hosptial of China Medical University
    • Shenyang, Liaoning, China, 110004
      • Shengjin Hospital of China Medical University
  • Shandong
    • Jinan, Shandong, China, 250063
      • Qilu Hospital of Shandong University
    • Qingdao, Shandong, China, 266003
      • The Affiliated Hosptial of Qingdao University
  • Shanghai
    • Shanghai, Shanghai, China, 200040
      • Shanghai Medical College of Fudan University
    • Shanghai, Shanghai, China, 200050
      • Shanghai Skin Disease Hospital Skin Disease Hospital of Tongji University
  • Shanxi
    • Xi'an, Shanxi, China, 710004
      • The Second Affiliated Hospital of Xi'an Jiaotong University
  • Sichuan
    • Chengdu, Sichuan, China, 610044
      • West China Hospital Sichuan University
  • Tianjin
    • Tianjin, Tianjin, China, 300052
      • Tianjin Medical University General Hospital
  • Tianjing
    • Tianjing, Tianjing, China, 300120
      • Tianjin Academy Of Traditional Chinese Medicine Affiliated Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Hangzhou Third People's Hospital
    • Hangzhou, Zhejiang, China, 310020
      • Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
    • Hangzhou, Zhejiang, China
      • The Second Affiliated Hosptial Zhejiang University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FMX101; FMX101 4% minocycline foam	Drug: FMX101; topically once daily
Placebo Comparator: Vehicle Foam	Drug: FMX101; topically once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ILC	The efficacy assessments will inflammation lesion counts at week12	Week12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Investigator Global Assessment (IGA)	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.	week 12
nILC	The efficacy assessments will non-inflammation lesion counts at baseline and week12	week 12
ILC week4	The Absolute Change From Baseline in the Inflammatory Lesion Count at Week 4	week 4
ILC week8	The Absolute Change From Baseline in the Inflammatory Lesion Count at Week 8	week 8
Investigator Global Assessment (IGA) week4	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.	Week 4
Investigator Global Assessment (IGA) week8	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.	Week 8

Collaborators and Investigators

• Sponsor: Cutia Therapeutics (Shanghai) Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2021
• Primary Completion (Actual): September 27, 2022
• Study Completion (Actual): October 14, 2022

Study Registration Dates

• First Submitted: July 9, 2021
• First Submitted That Met QC Criteria: July 9, 2021
• First Posted (Actual): July 14, 2021

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 26, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris; Anti-Infective Agents; Anti-Bacterial Agents; Minocycline
• Other Study ID Numbers: CU-10201-301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No