A Phase 2 Safety and Efficacy Study of UHE-101 Cream in Subjects With Acne Vulgaris

NCT03307577 | Completed Phase 2 FDA Drug

• 1 other identifier: 000-8651-202
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

UHE-101 cream, 1% ("UHE-101") is being developed for the topical treatment of acne vulgaris. The purpose of this study is to compare the safety and efficacy of twice daily topical application of UHE-101 cream for 12 weeks to its vehicle cream in subjects with facial acne vulgaris.

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (2)

• Investigator's Global Assessment (IGA) "Success"

  Proportion of subjects achieving success in each treatment group at Week 12 using the dichotomized IGA with success defined as a score of "clear" or "almost clear" (IGA Score of 0 or 1) and a two or more grade improvement from Baseline.

  Week 12

• Acne Lesion Counts (Absolute Change)

  Absolute change from Baseline in Acne Lesion Counts in each treatment group at Week 12.

  Week 12

Secondary Outcomes (7)

• IGA "Success"

  Week 4

• IGA "Success"

  Week 8

• Acne Lesion Counts (Absolute Change)

  Week 4

• Acne Lesion Counts (Absolute Change)

  Week 8

• Acne Lesion Counts (Percent Change)

  Week 4

Study Arms (2)

UHE-101 cream, 1%

EXPERIMENTAL

Cream is applied twice a day

Drug: UHE-101 Cream

Vehicle cream

PLACEBO COMPARATOR

Cream is applied twice a day

Other: Vehicle Cream

Interventions

UHE-101 Cream DRUG

Topical cream containing investigational drug at a concentration of 1%

UHE-101 cream, 1%

Vehicle Cream OTHER

Topical cream containing no drug (i.e., placebo)

Vehicle cream

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:

• Patient must provide written informed consent/assent. A patient under 18 years of age must provide written informed assent and be accompanied by the parent or legal guardian at the time of assent/consent signing. The parent or legal guardian must provide informed consent for the patient. If a patient becomes 18 years of age during the study, the patient must provide written informed consent at that time to continue study participation.
• Females must be post-menopausal, surgically sterile, or use an effective method of birth control.
• Patient has moderate to severe facial acne vulgaris.
• Patient must be in good general health as determined by the investigator and supported by medical history, physical and Vital Signs exam.

You may not qualify if:

• Females who are pregnant, lactating, or are planning to become pregnant during the study.
• Patient has active nodulocystic acne or acne conglobate, acne fulminans, or other forms of acne (e.g., acne mechanica).
• Patient has any skin pathology or condition that, in the investigator's opinion, could interfere with the evaluation of the test article or requires use of interfering topical, systemic, or surgical therapy.
• Patient has used any of the following topical anti-acne preparations or procedures on the face:
• Topical anti-acne treatments including, but not limited to, over the-counter (OTC) acne cleansers or treatments, benzoyl peroxide, antibiotics, azelaic acid, dapsone, sulfa based products, corticosteroids, and salicylic acid within two weeks of Baseline;
• Topical retinoids (e.g., tazarotene, adapalene, and tretinoin) within four weeks of Baseline;
• Light treatments, microdermabrasion, or chemical peels within eight weeks of Baseline;
• Other topical therapy, which may materially affect the patient's acne, in the investigator's opinion.
• Patient has used any of the following systemic anti-acne medications:
• Corticosteroids (including intramuscular and intralesional injections) within four weeks of Baseline. Inhaled, intranasal, or ocular corticosteroids are allowed if use is stable;
• Antibiotics or other systemic anti-acne medications within four weeks of Baseline, with the exception of five days or less of antibiotic therapy during this period, but not within one week of Baseline;
• Androgen receptor blockers (i.e., spironolactone or flutamide) within eight weeks of Baseline; with the exception of five days or less of spironolactone therapy during this period, but not within one week of Baseline;
• Retinoid therapy (e.g., isotretinoin) within six months of Baseline;
• Vitamin A supplements (greater than 10,000 units per day) within six months of Baseline;
• Other systemic therapy, which may materially affect the patient's acne, in the investigator's opinion.

Sponsors & Collaborators

• Therapeutics, Inc.: lead

Study Sites (1)

Site 02

San Diego, California, 92123, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is a double-blind study, which means that neither the patient nor the investigator will know which cream the patient is using.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2017
• First Posted: October 11, 2017
• Study Start: October 5, 2017
• Primary Completion: May 31, 2018
• Study Completion: May 31, 2018
• Last Updated: May 24, 2019

Record last verified: 2019-05

Locations

US (1)