Clinical trial NCT02431052: A Dose-ranging Study of DRM01 in Subjects With Acne Vulgaris
Official title: A Phase 2, Randomized, Double-blind, Vehicle-controlled, Dose-ranging Study of DRM01B Topical Gel in Subjects With Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acne Vulgaris
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2015-04-30
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objectives of this study are to assess the safety and efficacy DRM01 Topical Gel compared to vehicle in patients with acne vulgaris.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent.
* Male or non-pregnant, non-lactating females.
* Age ≥ 18 years.
* Clinical diagnosis of facial acne vulgaris defined as:
* At least 20 inflammatory lesions
* At least 20 non-inflammatory lesions
* Investigator Global Assessment of 3 or greater.

Exclusion Criteria:

* Active cystic acne or acne conglobata, acne fulminans, and secondary acne.
* Two or more active nodulocystic lesions.
* Screening clinical chemistry or hematology laboratory value that is considered clinically significant, in the opinion of the Investigator.
* Abnormal findings on screening ECG, deemed clinically significant, by the Investigator.
* Subjects who are actively participating in an experimental therapy study or who have received experimental therapy within 30 days or 5 half-lives (whichever is longer) of the Baseline visit.
* Subjects who are a poor medical risk because of other systemic diseases or active uncontrolled infections, in the opinion of the investigator.
* Treatment with over-the-counter topical medications for the treatment of acne vulgaris including benzoyl peroxide, topical anti-inflammatory medications, corticosteroids, α-hydroxy/glycolic acid on the face within 2 weeks prior to Baseline.
* Treatment with systemic corticosteroids (use of intranasal and inhaled corticosteroids allowed for seasonal allergies and asthma) within 4 weeks prior to Baseline.
* Treatment with systemic antibiotics or systemic anti-acne drugs or systemic anti-inflammatory drugs within 4 weeks prior to Baseline.
* Prescription topical retinoid use on the face within 4 weeks of Baseline (e.g., tretinoin, tazarotene, adapalene).
* Treatment with a new hormonal therapy or dose change to existing hormonal therapy within 12 weeks prior to Baseline. Dose and frequency of use of any hormonal therapy started more than 12 weeks prior to Baseline must remain unchanged throughout the study. Hormonal therapies include, but are not limited to, estrogenic and progestational agents such as birth control pills.
* Prior use of androgen receptor blockers (such as spironolactone or flutamide).
* Oral retinoid use (e.g., isotretinoin) within 12 months prior to Baseline or vitamin A supplements greater than 10,000 units/day within 6 months of Baseline.
* Facial procedures (chemical or laser peel, microdermabrasion, etc.) within the past 8 weeks or during the study.

Primary outcomes:
measure: Mean Absolute Change in Acne Lesion Counts (Inflammatory) From Baseline to Week 12
timeFrame: Baseline and Week 12
measure: Mean Absolute Change in Acne Lesion Counts (Non-inflammatory) From Baseline to Week 12
timeFrame: Baseline and Week 12
measure: Percentage of Subjects Who Achieved ≥ 2-grade Improvement and a Grade of 0 or 1 in the Investigator Global Assessment of Acne (IGA) From Baseline to Week 12
timeFrame: Baseline and Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Coastal Clinical Research, Inc.
state: Alabama
city: Encino
country: United States
facility: T. Joseph Raoof, MD, Inc.
state: California
city: San Diego
country: United States
facility: University Clinical Trials, Inc.
state: California
city: North Miami Beach
country: United States
facility: Tory Sullivan MD PA
state: Florida
city: Sanford
country: United States
facility: International Clinical Research - US, LLC
state: Florida
city: Tampa
country: United States
facility: MOORE Clinical Research, Inc.
state: Florida
city: Wellington
country: United States
facility: Visions Clinical Research
state: Florida
city: Louisville
country: United States
facility: DermResearch, PLLC
state: Kentucky
city: Rockville
country: United States
facility: Lawrence J. Green, MD, LLC
state: Maryland
city: Clinton Township
country: United States
facility: Michigan Center for Skin Care Research
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Fridley
country: United States
facility: Minnesota Clinical Study Center
state: Minnesota
city: Las Vegas
country: United States
facility: Las Vegas Dermatology
state: Nevada
city: Albuquerque
country: United States
facility: Academic Dermatology Associates
state: New Mexico
city: Rochester
country: United States
facility: Skin Search of Rochester, Inc.
state: New York
city: High Point
country: United States
facility: Dermatology Consulting Services
state: North Carolina
city: Knoxville
country: United States
facility: The Skin Wellness Center
state: Tennessee
city: Murfreesboro
country: United States
facility: International Clinical Research - Tennessee LLC
state: Tennessee
city: Austin
country: United States
facility: DermResearch, Inc
state: Texas
city: College Station
country: United States
facility: J&S Studies, Inc.
state: Texas
city: Houston
country: United States
facility: Center for Clinical Studies, LTD. LLP
state: Texas
city: Houston
country: United States
facility: Suzanne Bruce & Associates, PA. The Center for Skin Research
state: Texas
city: Katy
country: United States
facility: Suzanne Bruce & Associates, PA. The Center for Skin Research
state: Texas
city: Pflugerville
country: United States
facility: Austin Institute for Clinical Research
state: Texas
city: San Antonio
country: United States
facility: Progressive Clinical Research, PA
state: Texas
city: Salt Lake City
country: United States
facility: Dermatology Research Center, Inc.
state: Utah
city: Lynchburg
country: United States
facility: The Education & Research Foundation, Inc.
state: Virginia
city: Spokane
country: United States
facility: Premier Clinical Research
state: Washington
city: Calgary
country: Canada
facility: Kirk Barber Research
state: Alberta
city: Surrey
country: Canada
facility: Enverus Medical Research
state: British Columbia
city: Markham
country: Canada
facility: Lynderm Research
state: Ontario
city: Windsor
country: Canada
facility: Windsor Clinical Research, Inc.
state: Ontario
city: Montreal
country: Canada
facility: Innovaderm Research Inc.
state: Quebec
city: Quebec
country: Canada
facility: Centre de Recherche Dermetologique du Quebec Metropolitain (CRDQ)
Study officials:
affiliation: Dermira, Inc.
name: Beth Zib
role: STUDY_DIRECTOR
References: