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

Phase 3

Completed

• Conditions: Acne
• Interventions: Drug: IDP-121 Lotion; Drug: IDP-121 Vehicle Lotion

• Registration Number: NCT02932306
• Lead Sponsor: Bausch Health Americas, Inc.

Brief Summary

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 \[severe\]).

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11-03
• Study First Submitted: 2016-10-11
• Study First Submitted QC: 2016-10-11
• Study First Posted: 2016-10-13
• Primary Completion: 2017-02-22
• Study Completion: 2017-02-22
• Disposition First Submitted: 2018-01-05
• Disposition First Submitted QC: 2018-01-05
• Disposition First Posted: 2018-01-10
• Status Verified: 2019-12
• Results First Submitted: 2019-12-16
• Results First Submitted QC: 2019-12-16
• Last Update Submitted: 2019-12-16
• Results First Posted: 2020-01-03
• Last Update Posted: 2020-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 820

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Treatment Success at Week 12	Baseline, Week 12	Treatment success was defined as at least a 2-grade reduction from Baseline in EGSS score and an EGSS score equating to "Clear" or "Almost Clear". EGSS was based on a 5-point scale ranging from 0 to 4; where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe.
Absolute Change From Baseline in Mean Noninflammatory Lesion Count to Week 12	Baseline (Day 0), Week 12	Noninflammatory lesions were defined as follows: Open comedones (blackhead) - plugged hair follicle with dilated/open orifice, black in color; and Closed comedones (whitehead) - plugged hair follicle: small opening at skin surface. For noninflammatory facial lesions, open and closed comedones were recorded as a single count.
Absolute Change From Baseline in Mean Inflammatory Lesion Count to Week 12	Baseline, Week 12	Inflammatory lesions were defined as follows: Papule - a solid, elevated lesion less than 5 millimeters (mm); and Pustule - an elevated lesion containing pus less than 5 mm. For inflammatory facial lesions, papules and pustules were recorded as a single count, while nodular lesions were counted and recorded separately.

Secondary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Noninflammatory Lesion Count to Week 12	Baseline, Week 12	Noninflammatory lesions were defined as follows: Open comedones (blackhead) - plugged hair follicle with dilated/open orifice, black in color; and Closed comedones (whitehead) - plugged hair follicle: small opening at skin surface. For noninflammatory facial lesions, open and closed comedones were recorded as a single count.
Percent Change From Baseline in Inflammatory Lesion Count to Week 12	Baseline, Week 12	Inflammatory lesions were defined as follows: Papule - a solid, elevated lesion less than 5 millimeters (mm); and Pustule - an elevated lesion containing pus less than 5 mm. For inflammatory facial lesions, papules and pustules were recorded as a single count, while nodular lesions were counted and recorded separately.

Trial Locations

Locations (39)

Valeant Site 36; 🇺🇸 Guntersville, Alabama, United States

Valeant Site 14; 🇺🇸 Phoenix, Arizona, United States

Valeant Site 28; 🇺🇸 Hot Springs, Arkansas, United States

Valeant Site 38; 🇺🇸 Fountain Valley, California, United States

Valeant Site 34; 🇺🇸 Manhattan Beach, California, United States

Valeant Site 23; 🇺🇸 Oceanside, California, United States

Valeant Site 35; 🇺🇸 Rancho Cucamonga, California, United States

Valeant Site 20; 🇺🇸 San Diego, California, United States

Valeant Site 32; 🇺🇸 Denver, Colorado, United States

Valeant Site 10; 🇺🇸 Shelton, Connecticut, United States

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