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Completed

NCT Number: NCT03170388

A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group, Clinical Study in the Treatment of Acne Vulgaris

A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group, Clinical Study in the Treatment of Acne Vulgaris

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Key information

Conditions

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

Age range

9 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Valeant Site 01, Winnipeg, Manitoba, Canada

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About this study

A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group, Clinical Study Comparing the Efficacy and Safety of IDP-126 Gel in the Treatment of Acne Vulgaris

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female at least 9 years of age and older.
  • Written and verbal informed consent must be obtained. Subjects less than age of consent must sign an assent for the study and a parent or a legal guardian must sign the informed consent (if subject reaches age of consent during the study they should be re-consented at the next study visit).
  • Subject must have an EGSS of 3 (moderate) or 4 (severe) at the baseline visit.
  • Subjects with a facial acne inflammatory lesion (papules, pustules, and nodules) count no less than 20, but no more than 100.
  • Subjects with a facial acne non-inflammatory lesion (open and closed comedones) count no less than 30, but no more than 150.
  • Subjects with 2 or fewer facial nodules

Exclusion criteria

  • Use of an investigational drug or device within 30 days of enrollment or participation in a research study concurrent with this study.
  • Any dermatological conditions on the face that could interfere with clinical evaluations such as acne conglobata, acne fulminans, secondary acne, perioral dermatitis, clinically significant rosacea, gram negative folliculitis, dermatitis, eczema.
  • Any underlying disease(s) or some other dermatological condition of the face that requires the use of interfering topical or systemic therapy or makes evaluations and lesion count inconclusive.
  • Subjects with a facial beard or mustache that could interfere with the study assessments.
  • Subjects with more than 2 facial nodules.
  • Evidence or history of cosmetic-related acne.

Treatment and study plan

IDP-126 Gel

Drug

Gel

IDP-126 Component A

Drug

Component A

IDP-126 Component B

Drug

Component B

IDP-126 Component C

Drug

Component C

IDP-126 Vehicle Gel

Drug

Vehicle Gel

Primary outcomes

  1. Inflammatory Lesion Counts

    Time frame: Baseline to Week 12

    Absolute change from Baseline to Week 12 in mean inflammatory lesion counts

  2. Non-inflammatory Lesion Counts

    Time frame: Baseline to Week 12

    Absolute change from Baseline to Week 12 in mean non-inflammatory lesion counts

  3. Percentage of Participants With Success on the Evaluator's Global Severity Score

    Time frame: Baseline to Week 12

    Success was defined as at least a two grade reduction and clear or almost clear at Week 12. The Evaluator's Global Severity Score has grades for acne severity of 0 (Clear), 1 (Almost Clear), 2 (Mild), 3 (Moderate), and 4 (Severe), with higher scores indicating worse severity.

Secondary outcomes

  1. Inflammatory Lesion Count Changes at Week 2, 4, and 8

    Time frame: Baseline to Week 2, 4, 8

    Absolute change from Baseline to Week 2, 4, and 8 in mean inflammatory lesion counts

  2. Non-inflammatory Lesion Count Changes at Week 2, 4, and 8

    Time frame: Baseline to Week 2, 4, 8

    Absolute change from Baseline to Week 2, 4, and 8 in mean non-inflammatory lesion counts

  3. Inflammatory Lesion Count Percentage Changes at Week 2, 4, and 8

    Time frame: Baseline to Week 2, 4, 8

    Percentage change from Baseline to Week 2, 4, and 8 in mean inflammatory lesion counts

  4. Non-inflammatory Lesion Count Percentage Changes at Week 2, 4, and 8

    Time frame: Baseline to Week 2, 4, 8

    Percentage change from Baseline to Week 2, 4, and 8 in mean non-inflammatory lesion counts

  5. Percentage of Participants With Success on the Evaluator's Global Severity Score at Weeks 2, 4, and 8

    Time frame: Baseline to Week 2, 4, and 8

    Success was defined as at least a two grade reduction and clear or almost clear at the visit. The Evaluator's Global Severity Score has grades for acne severity of 0 (Clear), 1 (Almost Clear), 2 (Mild), 3 (Moderate), and 4 (Severe), with higher scores indicating worse severity.

  6. Percentage of Participants With Two Grade Success on the Evaluator's Global Severity Score - at Weeks 2, 4, and 8

    Time frame: Baseline to Week 2, 4, and 8

    Two grade success was defined as at least a two grade reduction. The Evaluator's Global Severity Score has grades for acne severity of 0 (Clear), 1 (Almost Clear), 2 (Mild), 3 (Moderate), and 4 (Severe), with higher scores indicating worse severity.

Sponsors and collaborators

Lead sponsor

Bausch Health Americas, Inc.

Industry

Registry information

Official study title

A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group, Clinical Study Comparing the Efficacy and Safety of IDP-126 Gel in the Treatment of Acne Vulgaris

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
May 31, 2017
Registry last updated
Nov 10, 2021

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.

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