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

Phase 4

Completed

Interventions: Drug: Trifarotene Vehicle
Drug: Trifarotene cream
Drug: Doxycycline hyclate
Drug: Doxycycline Placebo

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.

Recruitment & 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).

Arm && Interventions

Group	Intervention	Description
Trifarotene Vehicle + Doxycycline Placebo	Trifarotene Vehicle	Participants were applied with vehicle CD5789 topically on the face once daily in the evening for 12 weeks and received doxycycline matching placebo tablet orally once daily in the evening and 1 tablet in the morning on Day 2 of every week for 12 weeks.
Trifarotene Cream + Doxycycline	Trifarotene cream	Participants were applied with Trifarotene (CD5789) 50 micrograms per gram (mcg/g) cream topically on the face once daily in the evening for 12 weeks and received doxycycline 120 milligrams (mg) tablet orally once daily in the evening and 1 tablet in the morning on Day 2 of every week for 12 weeks.
Trifarotene Cream + Doxycycline	Doxycycline hyclate	Participants were applied with Trifarotene (CD5789) 50 micrograms per gram (mcg/g) cream topically on the face once daily in the evening for 12 weeks and received doxycycline 120 milligrams (mg) tablet orally once daily in the evening and 1 tablet in the morning on Day 2 of every week for 12 weeks.
Trifarotene Vehicle + Doxycycline Placebo	Doxycycline Placebo	Participants were applied with vehicle CD5789 topically on the face once daily in the evening for 12 weeks and received doxycycline matching placebo tablet orally once daily in the evening and 1 tablet in the morning on Day 2 of every week for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Absolute Change From Baseline in Facial Total Lesion Counts to Week 12	From Baseline 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.

Secondary Outcome Measures

Name	Time	Method
Absolute Change From Baseline in Facial Inflammatory Lesions (IL) Counts to Week 12	From Baseline to Week 12	All inflammatory lesions (papules, pustules, and nodular lesions) were counted by investigator/subinvestigator.
Absolute Change From Baseline in Facial Non Inflammatory Lesions (NIL) Counts to Week 12	From Baseline to Week 12	Non-inflammatory lesions (open and closed comedo) were counted by investigator/subinvestigator.
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	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.