Phase 4
Completed N=202
A Study to Compare Efficacy and Safety of Trifarotene Cream When Used With an Oral Antibiotic for the Treatment of Severe Acne Vulgaris (AV)
Source: ClinicalTrials.gov NCT04451330 ↗Enrolled (actual)
202
Serious AEs
0.5%
Results posted
May 2022
Primary outcomePrimary: Absolute Change From Baseline in Facial Total Lesion Counts to Week 12 — -69.1; -48.1 Lesion counts
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Absolute Change From Baseline in Facial Total Lesion Counts to Week 12 |
-69.1; -48.1 | — |
| SECONDARY Absolute Change From Baseline in Facial Inflammatory Lesions (IL) Counts to Week 12 |
-29.4; -19.5 | — |
| SECONDARY Absolute Change From Baseline in Facial Non Inflammatory Lesions (NIL) Counts to Week 12 |
-39.5; -28.2 | — |
| 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 |
31.7; 15.8 | — |
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).
Data sourced from ClinicalTrials.gov (NCT04451330). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.