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

NCT02535871 | Unknown Phase 3

• 1 other identifier: V01-121A-302
• Study Type: interventional
• Target: 800
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary objective of this study is to compare the efficacy, safety and tolerability of IDP-121 Lotion and vehicle in the treatment of subjects with acne vulgaris.

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (3)

• Absolute change in inflammatory lesion count from baseline to Week 12

  At each visit the Evaluator will count the total number of inflammatory lesions (papules, pustules, and nodules) on the subject's face. Inflammatory lesions are defined as follows: Papule - a small, solid elevation less than 5 mm in diameter. Most of the lesion is above the surface of the skin. Pustule - a small, circumscribed elevation less than 5 mm in diameter that contains yellow-white exudate. Nodule - a subcutaneous lesion greater than or equal to 5 mm in diameter.

  12 weeks

• Absolute change in non-inflammatory lesion count from baseline to Week 12

  At each visit the Evaluator will count the total number of non-inflammatory lesions (open and closed comedones). Non-inflammatory lesions are defined as follows: Open comedones (black head) - a lesion in which the follicle opening is widely dilated with the contents protruding out onto the surface of the skin. Closed comedones (white head)- a lesion in which the follicle opening is closed, but the sebaceous gland is enlarged by the pressure of the sebum build up, which in turn causes the skin around the follicle to thin and become elevated with a white appearance.

  12 weeks

• Proportion of subjects who have a least a 2 grade reduction at Week 12 from baseline in the Evaluator's Global Severity Score and were Clear or Almost Clear

  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 (papules must be resolving and may be hyperpigmented, though not pink-red) 2. Mild- Some non-inflammatory lesions are present, with few inflammatory lesions (papules/pustules only; no nodulo-cystic 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 nodulo-cystic lesion 4. Severe- Inflammatory lesions are more apparent, many comedones and papules/pustules, there may or may not be up to 2 nodulo-cystic lesions.

  12 weeks

Secondary Outcomes (3)

• Percent change in inflammatory lesion count from baseline to Week 4, 8, and 12

  4, 8, and 12 weeks

• Percent change in non-inflammatory lesion count from baseline to Week 4, 8, and 12

  4, 8, and 12 weeks

• Proportion of subjects who have a least a 2 grade reduction at Week 4, 8, and 12 from baseline in the Evaluator's Global Severity Score

  4, 8, and 12 weeks

Study Arms (2)

IDP-121 Lotion

EXPERIMENTAL

IDP-121 Lotion, applied topically to the face, once daily for 12 weeks.

Drug: IDP-121 Lotion

IDP-121 Lotion Vehicle

PLACEBO COMPARATOR

IDP-121 Vehicle Lotion, applied topically to the face, once daily for 12 weeks

Drug: IDP-121 Vehicle Lotion

Interventions

IDP-121 Lotion DRUG

Investigational Product: IDP-121 Lotion

IDP-121 Lotion

IDP-121 Vehicle Lotion DRUG

Comparator Product: IDP-121 Vehicle Lotion

IDP-121 Lotion Vehicle

Eligibility Criteria

• Age: 9 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 9 years of age and older
• Written and verbal informed consent must be obtained.
• Subject must have a score moderate or severe on the Evaluator's Global Severity assessment at the screening and baseline visit
• 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
• Concomitant use of potentially irritating over-the-counter products

Sponsors & Collaborators

• Valeant Pharmaceuticals: lead

MeSH Terms

Conditions

Acne Vulgaris

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 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2015
• First Posted: August 31, 2015
• Study Start: September 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: September 14, 2015

Record last verified: 2015-09