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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: Trifarotene cream
* Drug: Doxycycline hyclate
* Drug: Trifarotene Vehicle
* Drug: Doxycycline Placebo


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Trifarotene Cream + Doxycycline<br>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. | Drug: Trifarotene cream<br>* Trifarotene 50 mcg/g cream applied topically once daily on face for 12 weeks.<br>* Other names: AKLIEF;Drug: Doxycycline hyclate<br>* Doxycycline hyclate delayed release 120 mg tablets was administered orally for 12 weeks.<br>* Other names: DORYX MPC;|
| Placebo Comparator: Trifarotene Vehicle + Doxycycline Placebo<br>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. | Drug: Trifarotene Vehicle<br>* Trifarotene 50 mcg/g vehicle cream was applied topically once daily on face for 12 weeks.<br>Drug: Doxycycline Placebo<br>* Doxycycline hyclate delayed release 120 mg placebo tablets was administered orally for 12 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 |