Efficacy and Safety of IDP-121 and IDP-121 Vehicle Lotion in the Treatment of Acne Vulgaris

Bausch Health

Status and phase: Completed; Phase 3

Conditions: Acne

Treatments: Drug: IDP-121 Lotion; Drug: IDP-121 Vehicle Lotion

Study type: Interventional

Funder types: Industry

Identifiers

NCT02932306

V01-121A-301

Details and patient eligibility

About

The objective of this study was to evaluate the efficacy, safety, and tolerability of a once daily topical application of IDP-121 Lotion compared with its vehicle (IDP-121 Vehicle Lotion) in participants with moderate to severe acne vulgaris (acne) (that is, acne having an Evaluator's Global Severity Score [EGSS] of 3 [moderate] or 4 [severe]).

Enrollment: 820 patients

Sex: All

Ages: 9+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Male or female at least 9 years of age and older.
• Written and verbal informed consent must be obtained. Participants 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 participant reaches age of consent during the study they should be re-consented at the next study visit).
• Participant must have a score of 3 (moderate) or 4 (severe) on the EGSS assessment at the screening and baseline visit

Key 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.
• 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.
• Participants with a facial beard or mustache that could interfere with the study assessments.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

820 participants in 2 patient groups, including a placebo group

IDP-121 Lotion

Experimental group

Description:

IDP-121 lotion (tretinoin 0.05 percent \[%\]) will be applied topically to the face of participants with moderate to severe acne, once daily for 12 weeks.

Treatment:

Drug: IDP-121 Lotion

IDP-121 Vehicle Lotion

Placebo Comparator group

Description:

IDP-121 lotion vehicle will be applied topically to the face of participants with moderate to severe acne, once daily for 12 weeks.

Treatment:

Drug: IDP-121 Vehicle Lotion