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

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