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

Galderma

Status and phase: Completed; Phase 4

Conditions: Acne Vulgaris

Treatments: Drug: Doxycycline Placebo; Drug: Trifarotene Vehicle; Drug: Doxycycline hyclate; Drug: Trifarotene cream

Study type: Interventional

Funder types: Industry

Identifiers

NCT04451330

RD.06.SPR.202394

Details and patient eligibility

About

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.

Enrollment: 202 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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202 participants in 2 patient groups, including a placebo group

Trifarotene Cream + Doxycycline

Experimental group

Description:

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.

Treatment:

Drug: Trifarotene cream

Drug: Doxycycline hyclate

Trifarotene Vehicle + Doxycycline Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Trifarotene Vehicle

Drug: Doxycycline Placebo