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

Primary Purpose

Acne Vulgaris

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
FMX101
Sponsored by
Cutia Therapeutics (Shanghai) Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris

Eligibility Criteria

9 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Beijing Friendship Hospital, Capital Medical University
  • Xuanwu Hospital Capital Medical University
  • Peking University Shougang Hospital
  • Peking University Third Hospital
  • China-Japan Friendship Hospital
  • Beijing Tsinghua Changgung Hospital
  • The Southwest Hospital Of Amu
  • The First Affiliated Hospital Of Chongqing Medical University
  • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
  • The Second Affiliated Hospital of Guangzhou Medical University
  • Dermatology Hosptial of Southern Medical University
  • The Second Hospital Of Hebei Medical University
  • The Third Xiangya Hospital Of Central South University
  • Institute of Dermatology Chinese Academy of Medical Sciences
  • Wuxi People's Hospital
  • The First Bethune Hosptial of Jilin University
  • The First Hosptial of China Medical University
  • Shengjin Hospital of China Medical University
  • Qilu Hospital of Shandong University
  • The Affiliated Hosptial of Qingdao University
  • Shanghai Medical College of Fudan University
  • Shanghai Skin Disease Hospital Skin Disease Hospital of Tongji University
  • The Second Affiliated Hospital of Xi'an Jiaotong University
  • West China Hospital Sichuan University
  • Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
  • Tianjin Medical University General Hospital
  • Hangzhou Third People's Hospital
  • Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
  • The Second Affiliated Hosptial Zhejiang University School Of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

FMX101

Vehicle Foam

Arm Description

FMX101 4% minocycline foam

Vehicle Foam

Outcomes

Primary Outcome Measures

ILC
The efficacy assessments will inflammation lesion counts at week12

Secondary Outcome Measures

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.
nILC
The efficacy assessments will non-inflammation lesion counts at baseline and week12
ILC week4
The Absolute Change From Baseline in the Inflammatory Lesion Count at Week 4
ILC week8
The Absolute Change From Baseline in the Inflammatory Lesion Count at 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.
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.

Full Information

First Posted
July 9, 2021
Last Updated
September 26, 2023
Sponsor
Cutia Therapeutics (Shanghai) Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT04960930
Brief Title
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
September 17, 2021 (Actual)
Primary Completion Date
September 27, 2022 (Actual)
Study Completion Date
October 14, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cutia Therapeutics (Shanghai) Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Drug: FMX101 FMX101, 4% minocycline foam Drug: Vehicle Foam Vehicle Foam
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
372 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FMX101
Arm Type
Experimental
Arm Description
FMX101 4% minocycline foam
Arm Title
Vehicle Foam
Arm Type
Placebo Comparator
Arm Description
Vehicle Foam
Intervention Type
Drug
Intervention Name(s)
FMX101
Intervention Description
topically once daily
Primary Outcome Measure Information:
Title
ILC
Description
The efficacy assessments will inflammation lesion counts at week12
Time Frame
Week12
Secondary Outcome Measure Information:
Title
Investigator Global Assessment (IGA)
Description
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.
Time Frame
week 12
Title
nILC
Description
The efficacy assessments will non-inflammation lesion counts at baseline and week12
Time Frame
week 12
Title
ILC week4
Description
The Absolute Change From Baseline in the Inflammatory Lesion Count at Week 4
Time Frame
week 4
Title
ILC week8
Description
The Absolute Change From Baseline in the Inflammatory Lesion Count at Week 8
Time Frame
week 8
Title
Investigator Global Assessment (IGA) week4
Description
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.
Time Frame
Week 4
Title
Investigator Global Assessment (IGA) week8
Description
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.
Time Frame
Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Facility Information:
Facility Name
Beijing Friendship Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Facility Name
Xuanwu Hospital Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100053
Country
China
Facility Name
Peking University Shougang Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100144
Country
China
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
Facility Name
China-Japan Friendship Hospital
City
Beijin
State/Province
Beijin
ZIP/Postal Code
100029
Country
China
Facility Name
Beijing Tsinghua Changgung Hospital
City
Beijin
State/Province
Beijin
ZIP/Postal Code
102218
Country
China
Facility Name
The Southwest Hospital Of Amu
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400038
Country
China
Facility Name
The First Affiliated Hospital Of Chongqing Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400042
Country
China
Facility Name
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Facility Name
The Second Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510260
Country
China
Facility Name
Dermatology Hosptial of Southern Medical University
City
Yuexiu
State/Province
Guangdong
ZIP/Postal Code
510091
Country
China
Facility Name
The Second Hospital Of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050004
Country
China
Facility Name
The Third Xiangya Hospital Of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Facility Name
Institute of Dermatology Chinese Academy of Medical Sciences
City
Nanjin
State/Province
Jiangsu
ZIP/Postal Code
210042
Country
China
Facility Name
Wuxi People's Hospital
City
Wuxi
State/Province
Jiangsu
ZIP/Postal Code
214023
Country
China
Facility Name
The First Bethune Hosptial of Jilin University
City
Changchun
State/Province
Jiling
ZIP/Postal Code
130061
Country
China
Facility Name
The First Hosptial of China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110001
Country
China
Facility Name
Shengjin Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110004
Country
China
Facility Name
Qilu Hospital of Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250063
Country
China
Facility Name
The Affiliated Hosptial of Qingdao University
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266003
Country
China
Facility Name
Shanghai Medical College of Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Facility Name
Shanghai Skin Disease Hospital Skin Disease Hospital of Tongji University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200050
Country
China
Facility Name
The Second Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710004
Country
China
Facility Name
West China Hospital Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610044
Country
China
Facility Name
Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
City
Tianjing
State/Province
Tianjing
ZIP/Postal Code
300120
Country
China
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300052
Country
China
Facility Name
Hangzhou Third People's Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Facility Name
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310020
Country
China
Facility Name
The Second Affiliated Hosptial Zhejiang University School Of Medicine
City
Hangzhou
State/Province
Zhejiang
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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