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A Phase 3, Vehicle-controlled Efficacy and Safety Study of IDP-123 Lotion in the Treatment of Acne Vulgaris (301)

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Bausch Health

Status and phase

Completed
Phase 3

Conditions

Acne Vulgaris

Treatments

Drug: IDP-123 Vehicle Lotion
Drug: IDP-123 Lotion

Study type

Interventional

Funder types

Industry

Identifiers

NCT03168321
V01-123A-301

Details and patient eligibility

About

This is a multicenter, randomized, double-blind, vehicle-controlled, 12-week study designed to assess the safety, efficacy, and tolerability of IDP-123 Lotion in comparison with IDP-123 Vehicle Lotion.

Full description

This is a multi-center, randomized, double-blind, vehicle-controlled, 12-week study designed to assess the safety, efficacy, and tolerability of IDP-123 Lotion and IDP-123 Vehicle Lotion. To be eligible for the study subjects must be at least 9 years of age and have a clinical diagnosis of moderate to severe acne.

Enrollment

813 patients

Sex

All

Ages

9 to 99 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Male or female at least 9 years of age and older;
  2. 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);
  3. Subject must have a score of 3 (moderate) or 4 (severe) on the Evaluator's Global Severity assessment at the baseline visit;
  4. Subjects with facial acne inflammatory lesion (papules, pustules, and nodules) count no less than 20 but no more than 50;
  5. Subjects with facial acne non-inflammatory lesion (open and closed comedones) count no less than 25 but no more than 100;
  6. Subjects with two or fewer nodules

Exclusion criteria

  1. Use of an investigational drug or device within 30 days of enrollment or participation in a research study concurrent with this study;
  2. 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;
  3. 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;
  4. Subjects with a facial beard or mustache that could interfere with the study assessments;
  5. Subjects with more than two (2) facial nodules;
  6. Evidence or history of cosmetic-related acne

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

813 participants in 2 patient groups, including a placebo group

IDP-123 Lotion
Experimental group
Description:
Tazarotene 0.045% Lotion
Treatment:
Drug: IDP-123 Lotion
IDP-123 Vehicle Lotion
Placebo Comparator group
Description:
Vehicle Lotion
Treatment:
Drug: IDP-123 Vehicle Lotion

Trial documents
1

Trial contacts and locations

45

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Data sourced from clinicaltrials.gov

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