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A Study to Compare FCD105 Foam to Minocycline 3% Foam, Adapalene 0.3% Foam and Vehicle Foam.

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ClinicalTrials.gov Identifier: NCT04104685
Recruitment Status : Completed
First Posted : September 26, 2019
Last Update Posted : February 5, 2021
Information provided by (Responsible Party):
Vyne Therapeutics Inc.

Brief Summary:
A study comparing FCD105 to 3% minocycline foam, 0.3% adapalene foam and vehicle foam in patients ≥ 12 years old for the treatment of moderate-to-severe acne.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Combination Product: FCD105 Drug: 3% Minocycline Foam Drug: 0.3% Adapalene Foam Other: Vehicle Foam Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 446 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Prospective, Multicenter, Randomized, Double-Blind, Vehicle-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of a Combination of 3% Minocycline and 0.3% Adapalene Topical Foam Formulation for the Treatment of Moderate-to-Severe Acne (Study FX2016 40)
Actual Study Start Date : September 18, 2019
Actual Primary Completion Date : February 28, 2020
Actual Study Completion Date : March 3, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
Experimental: FCD105 Foam
FCD105 Foam
Combination Product: FCD105
Experimental combination

Active Comparator: 3% Minocycline Foam
3% Minocycline Foam
Drug: 3% Minocycline Foam
Active Comparator

Active Comparator: 0.3% Adapalene Foam
0.3% Adapalene Foam
Drug: 0.3% Adapalene Foam
Active Comparator

Placebo Comparator: Vehicle Foam
Vehicle Foam
Other: Vehicle Foam

Primary Outcome Measures :
  1. Absolute change from Baseline in inflammatory lesion counts at week 12 [ Time Frame: 12 weeks ]
    Statistical superiority of FCD105 vs. vehicle in the absolute change from Baseline in inflammatory lesion counts at Visit 4 (Week12/End of Treatment)

  2. Absolute change from Baseline in non-inflammatory lesion counts at week 12 [ Time Frame: 12 weeks ]
    Statistical superiority of FCD105 vs. vehicle in the absolute change from Baseline in non-inflammatory lesion counts at Visit 4 (Week12/End of Treatment)

  3. Investigator's Global Assessment (IGA) Treatment Success at Week 12 [ Time Frame: 12 weeks ]
    Statistical superiority of FCD105 vs. vehicle in in IGA Treatment Success at Visit 4 (Week 12/End of Treatment), where success is defined as an IGA score of 0 or 1, and at least a 2-grade improvement (decrease) from Baseline.

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Has facial acne vulgaris with all of the following:

    1. 20 to 50 inflammatory lesions (papules and/or pustules) on the face.
    2. 25 to 100 non-inflammatory lesions (open and closed comedones) on the face.
    3. IGA score of moderate (3) to severe (4).
  2. No more than two active nodules on the face.
  3. Willing to use only the supplied non-medicated 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. Female who is pregnant or lactating, or is planning a pregnancy during the study.
  2. Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne), or any dermatological condition of the face that could interfere with the clinical evaluations.
  3. Facial hair (eg, beard, mustache, etc.) that could interfere with the clinical evaluations.
  4. Sunburn on the face.
  5. Severe systemic disease as assessed by the Investigator that might interfere with the conduct of the study or the interpretation of the results.
  6. Subjects who have a documented history of any of the following:

    1. Allergy to tetracycline-class antibiotics or to any ingredient in the study drug.
    2. Pseudomembranous colitis or antibiotic-associated colitis.
    3. Hepatitis or clinically significant liver damage or clinically significant renal impairment.
    4. Known or suspected premalignant or malignant disease (excluding successfully treated skin cancers).
  7. Subjects who have used the following medications:

    Within 1 week prior to randomization:

    • Medicated facial cleansers on the face.
    • Topical acne treatments on the face (other than those listed below).

    Within 4 weeks prior to randomization:

    • Topical retinoids on the face.
    • Topical anti-inflammatories and/or corticosteroids on the face.
    • Topical corticosteroids on body areas other than the face for more than 15 consecutive days and on more than 10% of the body surface area. In body folds, such as axillary and inguinal regions, only mild topical steroids are allowed for short term use (≤15 consecutive days).
    • Systemic antibiotics.
    • Systemic acne treatments.

    Within 12 weeks prior to randomization:

    • Systemic retinoids.
    • Systemic corticosteroids (Note: Intranasal and inhaled corticosteroids may be used throughout the study if the subject is on a stable dose).
  8. Use of sauna during the 2 weeks prior to randomization.
  9. Epilation of the face within 2 weeks prior to randomization.
  10. Folliculitis on the face.
  11. Documented history of depression that is not, in the opinion of the Investigator, currently adequately controlled with medication

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04104685

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Sponsors and Collaborators
Vyne Therapeutics Inc.
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Responsible Party: Vyne Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT04104685    
Other Study ID Numbers: FX2016-40
First Posted: September 26, 2019    Key Record Dates
Last Update Posted: February 5, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Dermatologic Agents