Skip to main content
OpenTrials
Completed

NCT Number: NCT04960930

To Evaluate the Efficacy and Safety of Minocycline Hydrochloride Foam 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

9 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Beijing Tsinghua Changgung Hospital, Beijin, China

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

FMX101

Drug

topically once daily

Primary outcomes

  1. ILC

    Time frame: Week12

    The efficacy assessments will inflammation lesion counts at week12

Secondary outcomes

  1. Investigator Global Assessment (IGA)

    Time frame: week 12

    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.

  2. nILC

    Time frame: week 12

    The efficacy assessments will non-inflammation lesion counts at baseline and week12

  3. ILC week4

    Time frame: week 4

    The Absolute Change From Baseline in the Inflammatory Lesion Count at Week 4

  4. ILC week8

    Time frame: week 8

    The Absolute Change From Baseline in the Inflammatory Lesion Count at Week 8

  5. Investigator Global Assessment (IGA) week4

    Time frame: Week 4

    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.

  6. Investigator Global Assessment (IGA) week8

    Time frame: Week 8

    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.

Sponsors and collaborators

Lead sponsor

Cutia Therapeutics (Shanghai) Co., Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 14, 2021
Registry last updated
Sep 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.