A Dose-ranging Study of DRM01 in Subjects With Acne Vulgaris

Acne Vulgaris Clinical Trial

Official title:

A Phase 2, Randomized, Double-blind, Vehicle-controlled, Dose-ranging Study of DRM01B Topical Gel in Subjects With Acne Vulgaris

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02431052
• Other study ID #: DRM01B-ACN02
• Status: Completed
• Phase: Phase 2
• Start date: April 2015
• Est. completion date: April 2016

Study information

• Verified date: July 2021
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 420
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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, a-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.

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• Olumacostat Glasaretil

Other:
• Vehicle

Locations

Country	Name	City	State
Canada	Kirk Barber Research	Calgary	Alberta
Canada	Lynderm Research	Markham	Ontario
Canada	Innovaderm Research Inc.	Montreal	Quebec
Canada	Centre de Recherche Dermetologique du Quebec Metropolitain (CRDQ)	Quebec
Canada	Enverus Medical Research	Surrey	British Columbia
Canada	Windsor Clinical Research, Inc.	Windsor	Ontario
United States	Academic Dermatology Associates	Albuquerque	New Mexico
United States	DermResearch, Inc	Austin	Texas
United States	Michigan Center for Skin Care Research	Clinton Township	Michigan
United States	J&S Studies, Inc.	College Station	Texas
United States	Henry Ford Health System	Detroit	Michigan
United States	T. Joseph Raoof, MD, Inc.	Encino	California
United States	Minnesota Clinical Study Center	Fridley	Minnesota
United States	Dermatology Consulting Services	High Point	North Carolina
United States	Center for Clinical Studies, LTD. LLP	Houston	Texas
United States	Suzanne Bruce & Associates, PA. The Center for Skin Research	Houston	Texas
United States	Suzanne Bruce & Associates, PA. The Center for Skin Research	Katy	Texas
United States	The Skin Wellness Center	Knoxville	Tennessee
United States	Las Vegas Dermatology	Las Vegas	Nevada
United States	DermResearch, PLLC	Louisville	Kentucky
United States	The Education & Research Foundation, Inc.	Lynchburg	Virginia
United States	Coastal Clinical Research, Inc.	Mobile	Alabama
United States	International Clinical Research - Tennessee LLC	Murfreesboro	Tennessee
United States	Tory Sullivan MD PA	North Miami Beach	Florida
United States	Austin Institute for Clinical Research	Pflugerville	Texas
United States	Skin Search of Rochester, Inc.	Rochester	New York
United States	Lawrence J. Green, MD, LLC	Rockville	Maryland
United States	Dermatology Research Center, Inc.	Salt Lake City	Utah
United States	Progressive Clinical Research, PA	San Antonio	Texas
United States	University Clinical Trials, Inc.	San Diego	California
United States	International Clinical Research - US, LLC	Sanford	Florida
United States	Premier Clinical Research	Spokane	Washington
United States	MOORE Clinical Research, Inc.	Tampa	Florida
United States	Visions Clinical Research	Wellington	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Dermira, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Absolute Change in Acne Lesion Counts (Inflammatory) From Baseline to Week 12	Mean absolute change in acne lesion counts (inflammatory) from baseline to Week 12	Baseline and Week 12
Primary	Mean Absolute Change in Acne Lesion Counts (Non-inflammatory) From Baseline to Week 12	Mean absolute change in acne lesion counts (non-inflammatory) from baseline to Week 12	Baseline and Week 12
Primary	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	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; Scoring Criteria for Investigator Global Assessment 0 - Clear skin with no inflammatory or noninflammatory lesions; - Almost clear; rare noninflammatory lesions with no more than one small inflammatory lesion; - Mild severity; greater than Grade 1; some noninflammatory lesions with no more than a few inflammatory lesions (papules/pustules only, no nodular lesions); - Moderate severity; greater than Grade 2; up to many noninflammatory lesions and may have some inflammatory lesions, but no more than one small nodular lesion; - Severe; greater than Grade 3; up to many noninflammatory and inflammatory lesions, but no more than a few nodular lesions	Baseline and Week 12