A Safety, Tolerability and Preliminary Efficacy Study of DRM01B Topical Gel

NCT01936324 | Completed Phase 1 Results

• 1 other identifier: DRM01B-ACN01
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 12

Brief Summary

This is a Phase 1/2a study. The purpose of Phase 1 was to evaluate the safety and tolerability of DRM01B Topical Gel in 6 healthy volunteers. The purpose of Phase 2a was to assess the safety, tolerability and preliminary efficacy of DRM01B Topical Gel compared to vehicle in subjects with acne vulgaris on the face.

Conditions

Acne Vulgaris

Keywords

acne vulgaris

Outcome Measures

Primary Outcomes (3)

• Mean Absolute Change in Acne Lesion Counts (Inflammatory) From Baseline to Week 12 in Phase 2a

  Mean absolute change in acne lesion counts (inflammatory) from baseline to Week 12 in Phase 2a

  Baseline and Week 12

• Mean Absolute Change in Acne Lesion Counts (Non-inflammatory) From Baseline to Week 12 in Phase 2a

  Mean absolute change in acne lesion counts (non-inflammatory) from baseline to Week 12 in Phase 2a

  Baseline and Week 12

• Percentage of Subjects Who Achieved ≥ 2-grade Improvement in the Investigator Global Assessment of Acne (IGA) From Baseline to Week 12 in Phase 2a

  Percentage of subjects who achieved ≥ 2-grade improvement in the investigator global assessment of acne (IGA) from baseline to Week 12 in Phase 2a Scoring Criteria for Investigator Global Assessment 0 - Clear skin with no inflammatory or noninflammatory lesions 1. \- Almost clear; rare noninflammatory lesions with no more than one small inflammatory lesion 2. \- Mild severity; greater than Grade 1; some noninflammatory lesions with no more than a few inflammatory lesions (papules/pustules only, no nodular lesions) 3. \- 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 4. \- Severe; greater than Grade 3; up to many noninflammatory and inflammatory lesions, but no more than a few nodular lesions

  Baseline and Week 12

Study Arms (2)

Phase 1

EXPERIMENTAL

Olumacostat Glasaretil Gel, 7.5%, applied twice daily to the face for 7 days in healthy volunteers

Drug: Olumacostat Glasaretil Gel, 7.5%

Phase 2a

EXPERIMENTAL

Olumacostat Glasaretil Gel, 7.5%, or Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks

Drug: Olumacostat Glasaretil Gel, 7.5%; Other: Olumacostat Glasaretil Gel, Vehicle

Interventions

Olumacostat Glasaretil Gel, 7.5% DRUG

Gel containing Olumacostat Glasaretil

Also known as: DRM01

Phase 1; Phase 2a

Olumacostat Glasaretil Gel, Vehicle OTHER

Vehicle (placebo) gel

Phase 2a

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent
• Willing to comply with the requirements of the protocol
• Males or non-pregnant, non-lactating females
• Age ≥ 18 years
• Was in good health and free from any clinically significant disease, as determined by the investigator
• If female and of childbearing potential, was willing to use an accepted method of birth control during study participation and for 30 days after the last application of study drug. Females were considered to be of childbearing potential unless they had been surgically sterilized (hysterectomy, bilateral oophorectomy, tubal ligation), had been diagnosed as infertile, had a same-sex partner or vasectomized male partner, were postmenopausal for at least 1 year, or were abstinent. Acceptable methods of birth control were defined as: abstinence, oral contraceptives, contraceptive patches/implants; Depo-Provera®, double barrier methods (e.g., condom and spermicide) or an intrauterine device (IUD). The birth control method must have been stable/unchanged for 30 days prior to baseline.
• If male, was vasectomized or agreed to use an accepted method of birth control with female partner during study participation and for 30 days after the last application of study drug.

You may not qualify if:

• Females who were pregnant, planning to become pregnant during the course of the study, or were breast-feeding
• Had a known hypersensitivity to DRM01B or its excipients
• Had any skin condition that may have interfered with the safety evaluations during the study
• Had a clinical chemistry or hematology laboratory value at screening that was considered clinically significant, in the opinion of the investigator
• Participated in an investigational drug study within 30 days prior to screening
• Were considered a poor medical risk because of other systemic diseases or active uncontrolled infections, in the opinion of the investigator. Any other condition which, in the judgment of the investigator, would put the subject at unacceptable risk for participation in the study.
• Signed informed consent
• Willing to comply with the requirements of the protocol
• Male or non-pregnant, non-lactating females
• Age ≥ 18 years
• If female and of childbearing potential, was willing to use an accepted method of birth control during study participation and for 30 days after the last study drug application. Females were considered to be of childbearing potential unless surgically sterilized (hysterectomy, bilateral oophorectomy, tubal ligation), had been diagnosed as infertile, had same sex partner or vasectomized male partner, or were postmenopausal for at least 1 year. Acceptable methods of birth control were defined as: abstinence, oral contraceptives, contraceptive patches/implants; Depo-Provera®, double barrier methods (e.g., condom and spermicide) or an IUD. The birth control method must have been stable/unchanged for 12 weeks prior to baseline and must have remained unchanged during study participation.
• If male, was vasectomized or agreed to use an accepted method of birth control with female partner during study participation and for 30 days after the last study drug application.
• Subjects were in good health and free from any disease that, in the opinion of the investigator, would have put the subject at risk during participation in the study.
• Clinical diagnosis of facial acne vulgaris defined as:
• At least 20 inflammatory lesions

Sponsors & Collaborators

• Dermira, Inc.: lead

Study Sites (12)

Guildford Dermatology Specialist Inc

Surrey, British Columbia, V3R 6A7, Canada

Location

Ultranova Skincare

Barrie, Ontario, L4M 6L2, Canada

Location

Lynderm Research Inc

Markham, Ontario, L3P1A8, Canada

Location

Institute of Cosmetic & Laser Surgery

Oakville, Ontario, L6J 7W5, Canada

Location

Skin Centre for Dermatology

Peterborough, Ontario, K9J 1Z2, Canada

Location

The Centre for Dermatology

Richmond Hill, Ontario, L4B 1A5, Canada

Location

Research Toronto

Toronto, Ontario, M5S 3B4, Canada

Location

K. Papp Clinical Research Inc.

Waterloo, Ontario, N2J 1C4, Canada

Location

Windsor Clinical Research, Inc.

Windsor, Ontario, N8W 5W7, Canada

Location

Innovaderm Research, Inc

Montreal, Quebec, H2K 4L5, Canada

Location

Siena Medical Research

Montreal, Quebec, H3Z 2S6, Canada

Location

Centre de Recherche Dermetologique du Quebec Metropolitain (CRDQ)

Québec, G1V 4X7, Canada

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

Study Officials

• Janice Drew

  Dermira, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2013
• First Posted: September 6, 2013
• Study Start: August 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: July 20, 2021
• Results First Posted: May 10, 2019

Record last verified: 2021-07

Locations

CA (12)