Study to Compare the Safety and Efficacy of IDP-123 Lotion to Tazorac Cream in the Treatment of Acne Vulgaris

Condition(s) targeted: Acne Vulgaris

Intervention: IDP-123 Lotion (Drug); Tazorac Cream, 0.1%, (Drug); Vehicle Cream (Drug); Vehicle Lotion (Drug)

Phase: Phase 2

Status: Not yet recruiting

Sponsored by: Valeant Pharmaceuticals

Official(s) and/or principal investigator(s):
Anya Loncaric, MS, Study Director, Affiliation: Valeant Pharmaceuticals

Overall contact:
Anya Loncaric, MS, Phone: 510-259-5284, Email: aloncaric@solta.com

The primary objective of this study is to compare the safety and efficacy of once daily application of IDP-123 Lotion to Tazorac Cream, 0. 1%, Vehicle Lotion, and Vehicle Cream in subjects with moderate to severe acne vulgaris.

Official title: A Phase 2, Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study to Compare the Safety and Efficacy of IDP-123 Lotion to Tazorac® (Tazarotene) Cream, 0.1%, in the Treatment of Acne Vulgaris

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Absolute change in mean inflammatory lesion counts at Week 12

Absolute change in mean non-inflammatory lesion counts at Week 12

Percent of subjects who achieve at least a two-grade reduction from baseline and are Clear or Almost Clear at Week 12 in the Evaluator's Global Severity Score

Secondary outcome:

Mean percent change in inflammatory lesion count from baseline at Weeks 2, 4, 8, and 12.

Mean percent change in non-inflammatory lesion counts from baseline at Weeks 2, 4, 8 and 12.

The proportion of subjects with at least a two grade improvement in the Evaluator's Global Severity Score from baseline at Weeks 2, 4, 8 and 12.

Detailed description: This is a multi-center, randomized, double-blind, vehicle-controlled, 12-week study designed to assess the safety, tolerability, and efficacy of IDP-123 Lotion in comparison with Tazorac Cream, Vehicle Lotion, and Vehicle Cream in subjects with moderate to severe acne. Treatment success will be evaluated by changes in inflammatory and non-inflammatory lesion counts, as well as treatment success using an Evaluator's Global Severity Score. IDP-123 is a lotion for the topical treatment of acne.

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Male or female at least 12 years of age and older

- Written and verbal informed consent must be obtained

- Subject must have a score of moderate or severe on the Evaluator's Global Severity

assessment

- Subjects with facial acne inflammatory lesion (papules, pustules, and nodules) count

no less than 20 but no more than 40

- Subjects with facial acne non-inflammatory lesion (open and closed comedones) count

no less than 20 but no more than 100

- Subjects with two or fewer facial nodules

- Pre-menses females and women of childbearing potential must have a negative urine

pregnancy test at the screening and baseline visits and must be willing to practice effective contraception for the duration of the study

- Subjects must be willing to comply with study instructions and return to the clinic

for required visits

- Subjects must be willing to use only allowed cleansers, moisturizers, sunscreens, or

moisturizer/sunscreen combination products. If the subject wears makeup they must agree to use non-comedogenic makeup. 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

- 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 two (2) facial nodules

- Evidence or history of cosmetic-related acne

- Subject has a history of experiencing significant burning or stinging when applying

any facial treatment to their face

- Female subjects who are pregnant, nursing mothers, planning a pregnancy during the

course of the trial, or become pregnant during the study

- Use of estrogens for less than 12 weeks immediately preceding study entry

- If female, subject has a history of hirsutism, polycystic ovarian disease or

clinically significant menstrual irregularities

- Treatment of any type of cancer within the last 6 months

- Subject uses medications and/or vitamins during the study which are reported to

exacerbate acne

- History of hypersensitivity or allergic reactions to any of the study preparations as

described in the Investigator's Brochure

- Subjects taking drugs known to be photosensitizers

- Concomitant use of potentially irritating over-the-counter products that contain

ingredients such as benzoyl peroxide, alpha-hydroxy acid, salicylic acid, retinol or glycolic acids

- Subjects that have not undergone the specified washout period(s) for specified

topical preparations used on the face or subjects who require the concurrent use of specified topical agents in the treatment area

- Subjects that have not undergone the specified washout period(s) for specified

systemic medications or subjects who require the concurrent use of specified systemic medications

- Subject intends to use a tanning booth or sunbathe during the study

- Subjects who are unable to communicate or cooperate with the Investigator

- Subjects with any underlying disease that the Investigator deems uncontrolled, and

poses a concern for the subjects safety while participating in the study

Anya Loncaric, MS, Phone: 510-259-5284, Email: aloncaric@solta.com

Starting date: September 2015
Last updated: August 14, 2015