A Study to Compare Efficacy and Safety of Trifarotene Cream When Used With an Oral Antibiotic for the Treatment of Severe Acne Vulgaris (AV)

Acne Vulgaris Clinical Trial

— DUAL  

Official title:

A Multi-Center, Randomized, Double-Blind, Placebo Controlled Study To Compare Efficacy and Safety of Trifarotene (CD5789) Cream When Used Withan Oral Antibiotic for the Treatment of Severe Acne Vulgaris

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04451330
• Other study ID #: RD.06.SPR.202394
• Status: Completed
• Phase: Phase 4
• Start date: July 29, 2020
• Est. completion date: April 26, 2021

Study information

• Verified date: April 2021
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to demonstrate that daily use of topical trifarotene (CD5789) 50 microgram per gram (mcg/g) cream when used in association with oral antibiotic is safe and effective for the treatment of severe AV.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: April 26, 2021
• Est. primary completion date: April 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• Participants with clinical diagnosis of acne vulgaris, defined by IGA score of 4 (Severe)

• Participants with at least 20 inflammatory lesions (papules and pustules) and 30 to 120 non-inflammatory lesions (open comedones and closed comedones) and no more than 2 nodules (less than [<]1 centimeter [cm] in diameter) on the face, excluding the nose

• Agrees to provide written informed consent

• Participant is a female of non-childbearing potential (premenarchal or postmenopausal [absence of menstrual bleeding for 1 year prior to Screening, without any other medical reason], hysterectomy or bilateral oophorectomy)

Exclusion Criteria:

• Participant with any acne cyst on the face

• Participants with nodulocystic or conglobate acne, acne fulminans, or secondary acne (chloracne, drug-induced acne, etc.)

• Participants with facial dermal conditions (example [e.g.] tattoo, skin abrasion, eczema, sunburned skin, scars, nevi, etc.) that may interfere with study assessments in the opinion of the investigator

• Participants who is at risk in terms of precautions, warnings, and contraindications for trifarotene or doxycycline hyclate

• Currently receiving any prescription testosterone therapy (e.g., testosterone cypionate, testosterone enanthate, testosterone pellet, testosterone undecanoate) or on a testosterone booster or prescription testosterone (e.g., dehydroepiandrosterone [DHEA], Omnadren, Sustanon, testosterone cypionate, testosterone enanthate, testosterone propionate, testosterone phenylpropionate) or testosterone supplements (e.g., Tribulus).

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• Trifarotene cream
Trifarotene 50 mcg/g cream applied topically once daily on face for 12 weeks.
• Doxycycline hyclate
Doxycycline hyclate delayed release 120 mg tablets was administered orally for 12 weeks.
• Trifarotene Vehicle
Trifarotene 50 mcg/g vehicle cream was applied topically once daily on face for 12 weeks.
• Doxycycline Placebo
Doxycycline hyclate delayed release 120 mg placebo tablets was administered orally for 12 weeks.

Locations

Country	Name	City	State
Puerto Rico	Galderma Investigational Site	Aibonito
United States	Galderma Investigational Site	Arlington	Texas
United States	Galderma Investigational Site	Aventura	Florida
United States	Galderma Investigational Site	Boca Raton	Florida
United States	Galderma Investigational Site	Charleston	South Carolina
United States	Galderma Investigational Site	Dallas	Texas
United States	Galderma Investigational Site	Evansville	Indiana
United States	Galderma Investigational Site	Fort Smith	Arkansas
United States	Galderma Investigational Site	Grapevine	Texas
United States	Galderma Investigational Site	High Point	North Carolina
United States	Galderma Investigational Site	Hot Springs	Arkansas
United States	Galderma Investigational Site	Knoxville	Tennessee
United States	Galderma Investigational Site	Las Vegas	Nevada
United States	Galderma Investigational Site	Miramar	Florida
United States	Galderma Investigational Site	New Albany	Indiana
United States	Galderma Investigational Site	New Brighton	Minnesota
United States	Galderma Investigational Site	Newnan	Georgia
United States	Galderma Investigational Site	Newport Beach	California
United States	Galderma Investigational Site	Pflugerville	Texas
United States	Galderma Investigational Site	Rockville	Maryland
United States	Galderma Investigational Site	Rogers	Arkansas
United States	Galderma Investigational Site	San Antonio	Texas
United States	Galderma Investigational Site	San Antonio	Texas
United States	Galderma Investigational Site	Stony Brook	New York
United States	Galderma Investigational Site	Sugarloaf	Pennsylvania
United States	Galderma Investigational Site	Warren	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute Change From Baseline in Facial Total Lesion Counts to Week 12	Total lesion counts corresponded to the sum of inflammatory and non-inflammatory lesions, and papules. The investigator (or subinvestigator) counted all inflammatory lesions (papules, pustules, and nodular lesions) and non-inflammatory lesions (open and closed comedos; diagnosis based on palpation) on the face.	From Baseline to Week 12
Secondary	Absolute Change From Baseline in Facial Inflammatory Lesions (IL) Counts to Week 12	All inflammatory lesions (papules, pustules, and nodular lesions) were counted by investigator/subinvestigator.	From Baseline to Week 12
Secondary	Absolute Change From Baseline in Facial Non Inflammatory Lesions (NIL) Counts to Week 12	Non-inflammatory lesions (open and closed comedo) were counted by investigator/subinvestigator.	From Baseline to Week 12
Secondary	Percentage of Participants Who Achieved an IGA Score of 1 (Almost Clear) or 0 (Clear) and At Least a 2-Grade Improvement From Baseline to Week 12	IGA was an assessment scale used to evaluate facial acne severity. IGA was recorded from components collected on the case report form (CRF) using a 5-point scale where (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on inflammation, pustules and papulation/infiltration. Success Rate was defined as the percentage of participants who achieved an IGA score of 1 (Almost Clear) or 0 (Clear) and at least a 2-grade improvement from Baseline to Week 12.	From Baseline to Week 12