Clinical trial NCT04451330: A Study to Compare Efficacy and Safety of Trifarotene Cream When Used With an Oral Antibiotic for the Treatment of Severe Acne Vulgaris (AV)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acne Vulgaris
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2020-06-30
Enrollment: 202
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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).

Primary outcomes:
measure: Absolute Change From Baseline in Facial Total Lesion Counts to Week 12
timeFrame: From Baseline to Week 12
Secondary outcomes:
measure: Absolute Change From Baseline in Facial Inflammatory Lesions (IL) Counts to Week 12
timeFrame: From Baseline to Week 12
measure: Absolute Change From Baseline in Facial Non Inflammatory Lesions (NIL) Counts to Week 12
timeFrame: From Baseline to Week 12
measure: 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
timeFrame: From Baseline to Week 12
Other outcomes:
Locations:
city: Fort Smith
country: United States
facility: Galderma Investigational Site
state: Arkansas
city: Hot Springs
country: United States
facility: Galderma Investigational Site
state: Arkansas
city: Rogers
country: United States
facility: Galderma Investigational Site
state: Arkansas
city: Newport Beach
country: United States
facility: Galderma Investigational Site
state: California
city: Aventura
country: United States
facility: Galderma Investigational Site
state: Florida
city: Boca Raton
country: United States
facility: Galderma Investigational Site
state: Florida
city: Miramar
country: United States
facility: Galderma Investigational Site
state: Florida
city: Newnan
country: United States
facility: Galderma Investigational Site
state: Georgia
city: Evansville
country: United States
facility: Galderma Investigational Site
state: Indiana
city: New Albany
country: United States
facility: Galderma Investigational Site
state: Indiana
city: Rockville
country: United States
facility: Galderma Investigational Site
state: Maryland
city: Warren
country: United States
facility: Galderma Investigational Site
state: Michigan
city: New Brighton
country: United States
facility: Galderma Investigational Site
state: Minnesota
city: Las Vegas
country: United States
facility: Galderma Investigational Site
state: Nevada
city: Stony Brook
country: United States
facility: Galderma Investigational Site
state: New York
city: High Point
country: United States
facility: Galderma Investigational Site
state: North Carolina
city: Sugarloaf
country: United States
facility: Galderma Investigational Site
state: Pennsylvania
city: Charleston
country: United States
facility: Galderma Investigational Site
state: South Carolina
city: Knoxville
country: United States
facility: Galderma Investigational Site
state: Tennessee
city: Arlington
country: United States
facility: Galderma Investigational Site
state: Texas
city: Dallas
country: United States
facility: Galderma Investigational Site
state: Texas
city: Grapevine
country: United States
facility: Galderma Investigational Site
state: Texas
city: Pflugerville
country: United States
facility: Galderma Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Galderma Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Galderma Investigational Site
state: Texas
city: Aibonito
country: Puerto Rico
facility: Galderma Investigational Site
Study officials:
References: