Skip to main content
OpenTrials
Completed

NCT Number: NCT03271021

A Study to Evaluate the Efficacy and Safety of Topical Administration of FMX101 in the Treatment of Moderate-to-Severe Acne Vulgaris

A Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Efficacy and Safety of Topical Administration of FMX101 for 12 Weeks in the Treatment of Moderate-to-Severe Acne Vulgaris (Study FX2017-22)

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

Foamix Investigational Site #376, Phoenix, Arizona, United States

Loading trial locations.

About this study

This is a randomized, multicenter, double-blind, vehicle-controlled, 2 arm study to evaluate the safety and efficacy over 12 weeks of FMX101 topical foam containing 4% minocycline compared to vehicle in the treatment of subjects with moderate-to-severe facial acne vulgaris. Qualified subjects will be randomized to receive 1 of the following 2 treatments:

  • FMX101 4% minocycline foam
  • Vehicle foam

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

FMX101, 4% minocycline foam

Vehicle Foam

Drug

Vehicle Foam

Primary outcomes

  1. The Absolute Change From Baseline in the Inflammatory Lesion Count at Week 12.

    Time frame: 12 weeks

    A decrease in the inflammatory lesion count from Baseline to Week 12.

  2. Investigator Global Assessment (IGA) Treatment Success (Dichotomized as Yes/no) at Week 12, Where Success is Defined as an IGA Score of 0 or 1, and at Least a 2-grade Improvement (Decrease) From Baseline

    Time frame: 12 weeks

Secondary outcomes

  1. The Absolute Change From Baseline in the Non-inflammatory Lesion Count at Week 12

    Time frame: 12 weeks

  2. The Absolute Change From Baseline in the Inflammatory Lesion Count at Week 9

    Time frame: 9 weeks

  3. The Absolute Change From Baseline in the Inflammatory Lesion Count at the Interim Visit at Week 6

    Time frame: 6 weeks

  4. IGA Treatment Success (Dichotomized as Yes/no) at Week 6, Where Success is Defined as an IGA Score of 0 or 1, and at Least a 2-grade Improvement (Decrease) From Baseline at the Interim Visit at Week 6

    Time frame: 6 weeks

  5. IGA Treatment Success (Dichotomized as Yes/no) at Week 9, Where Success is Defined as an IGA Score of 0 or 1, and at Least a 2-grade Improvement (Decrease) From Baseline at the Interim Visit at Week 9

    Time frame: 9 weeks

Sponsors and collaborators

Lead sponsor

Vyne Therapeutics Inc.

Industry

Registry information

Official study title

A Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Efficacy and Safety of Topical Administration of FMX101 for 12 Weeks in the Treatment of Moderate-to-Severe Acne Vulgaris (Study FX2017-22)

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 1, 2017
Registry last updated
Jan 18, 2022

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.