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

NCT02525822 | Unknown Phase 2

• 1 other identifier: V01-123A-201
• Study Type: interventional
• Target: 210
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (3)

• Absolute change in mean inflammatory lesion counts at Week 12

  Facial area lesion counts will be taken from the subject's face by the Evaluator at each visit and the change at week 12 from baseline will be calculated. Facial inflammatory lesions (pustules, papules, and nodules) will be counted as follows: pustules and papules will be counted and recorded together, not separately; nodular lesions will be counted and recorded separately. Inflammatory lesions are defined as follows: Papule - a solid, elevated lesion less than 5 mm; Pustule - an elevated lesion containing pus less than 5 mm; Nodule - palpable subcutaneous lesion greater than 5 mm; has depth, not necessarily elevated

  12 weeks

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

  Facial area lesion counts will be taken from the subject's face by the Evaluator at each visit, and the change at week 12 from baseline will be calculated. Non-inflammatory lesions (open and closed comedones) will be counted and recorded together. Non-inflammatory lesions are defined as follows: Open comedones (blackhead) - plugged hair follicle with dilated/open orifice, black in color; Closed comedones (whitehead) - plugged hair follicle: small opening at skin surface

  12 weeks

• 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

  At each visit the severity will be determined based on evaluator-blinded evaluations of the signs and symptoms of acne vulgaris. Evaluations will be scored on a scale of 0-4 (Evaluator's Global Severity Score), with 0 being clear and 4 being severe. Please see below for complete definitions. 0 - Clear - Normal, clear skin with no evidence of acne vulgaris 1. Almost clear- Rare non-inflammatory lesions present, with rare non-inflamed papules 2. Mild- Some non-inflammatory lesions are present, with few inflammatory lesions (papules/pustules only; no nodulocystic lesions) 3. Moderate-Non-inflammatory lesions predominate, with multiple inflammatory lesions evident: several to many comedones and papules/pustules, and there may or may not be one nodulocystic lesion 4. Severe- Inflammatory lesions are more apparent, many comedones and papules/pustules, there may or may not be up to 2 nodulocystic lesions.

  12 weeks

Secondary Outcomes (3)

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

  2, 4, 8, and 12 weeks

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

  2, 4, 8, and 12 weeks

• 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.

  2, 4, 8, and 12 weeks

Study Arms (4)

IDP-123 Lotion

EXPERIMENTAL

IDP-123 Lotion, applied topically to the face, once daily for 12 weeks.

Drug: IDP-123 Lotion

Tazorac Cream, 0.1%

ACTIVE COMPARATOR

Tazorac Cream (tazarotene 0.1%), applied topically to the face, once daily for 12 weeks.

Drug: Tazorac Cream, 0.1%,

Vehicle Cream

PLACEBO COMPARATOR

Vehicle Cream, applied topically to the face, once daily for 12 weeks.

Drug: Vehicle Cream

Vehicle Lotion

PLACEBO COMPARATOR

Vehicle Lotion, applied topically to the face, once daily for 12 weeks.

Drug: Vehicle Lotion

Interventions

IDP-123 Lotion DRUG

Investigational Product: IDP-123 Lotion

IDP-123 Lotion

Tazorac Cream, 0.1%, DRUG

Comparator Product: Tazorac Cream, 0.1%

Also known as: tazarotene

Tazorac Cream, 0.1%

Vehicle Cream DRUG

Comparator Product: Vehicle Cream

Vehicle Cream

Vehicle Lotion DRUG

Comparator Product: Vehicle Lotion

Vehicle Lotion

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Pre-menses females and women of childbearing potential must have a negative urine pregnancy test at the screening and baseline visits
• Subjects must be willing to comply with study instructions and return to the clinic for required visits

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Valeant Pharmaceuticals: lead

MeSH Terms

Conditions

Acne Vulgaris

Interventions

tazarotene

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Study Officials

• Anya Loncaric, MS

  Valeant Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Anya Loncaric, MS

CONTACT

510-259-5284; aloncaric@solta.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2015
• First Posted: August 17, 2015
• Study Start: September 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: September 14, 2015

Record last verified: 2015-09