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NCT02556788
A Multi-Center, Randomized, Double-Blind, Parallel-Group Vehicle Controlled Study To Compare The Efficacy And Safety Of CD5789 (Trifarotene) 50µg/g Cream Versus Vehicle Cream In Subjects With Acne Vulgaris
Phase 3 trial testing CD5789 (trifarotene) 50µg/g Cream in Acne Vulgaris in 1,212 participants. Completed in 12 May 2017.
7 February 2017
Quick facts
| Lead sponsor | Galderma R&D |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 1,212 |
| Start date | 1 November 2015 |
| Primary completion | 7 February 2017 |
| Estimated completion | 12 May 2017 |
| Sites | 81 locations across United States, Czechia, Hungary, Poland, Romania, Russia, Spain, Ukraine |
Drugs / interventions tested
- CD5789 (trifarotene) 50µg/g Cream — full drug profile →
- Placebo Cream
Conditions studied
- Acne Vulgaris — all drugs for Acne Vulgaris →
Sponsor
Galderma R&D — full company profile →
Who can join
9 and older, any sex, with Acne Vulgaris. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Investigator Global Assessment (IGA) Score of 1 (Almost Clear) or 0 (Clear)
Time frame: From Baseline to Week 12
Number of subjects who achieved an Investigator Global Assessment (IGA) score of 1 (almost clear) or 0 (Clear) and at least a 2-grade improvement from Baseline to Week 12.
Sponsor's own description
Assessment of the efficacy and safety of CD5789 (Trifarotene) 50µg/g cream applied once daily for 12 weeks in subjects with acne vulgaris.
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
-
Trifarotene: A Current Review and Perspectives in Dermatology.
Cosio T, Di Prete M, Gaziano R, Lanna C, et al · · 2021 · cited 44× · PMID 33652835 · DOI 10.3390/biomedicines9030237 -
Truncal Acne: An Overview.
Woo YR, Kim HS. · · 2022 · cited 9× · PMID 35806952 · DOI 10.3390/jcm11133660 -
Trifarotene: A Novel Therapeutic Option for Acne.
Naik PP. · · 2022 · cited 7× · PMID 35668721 · DOI 10.1155/2022/1504303 -
Comparison of the Efficacy of Clascoterone, Trifarotene, and Tazarotene for the Treatment of Acne: A Systematic Literature Review and Meta-Analysis.
Shergill M, Ali MU, Abu-Hilal M. · · 2024 · cited 5× · PMID 38733511 · DOI 10.1007/s13555-024-01175-3 -
Recommendations to Improve Outcomes in Acne and Acne Sequelae: A Focus on Trifarotene and Other Retinoids.
Issa N, Alexis A, Baldwin H, Hamzavi I, et al · · 2025 · cited 2× · PMID 39984798 · DOI 10.1007/s13555-025-01344-y -
Patient Insights on Acne Hyperpigmentation, Trifarotene, and Skincare: 6-Month, LEAP Phase 4 Qualitative Exit Interview Findings.
Dias-Barbosa C, Taylor N, Chan K, York JP, et al · · 2026 · PMID 41286546 · DOI 10.1007/s40271-025-00789-9
Verify or expand the search:
- PubMed search for NCT02556788
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Acne Vulgaris
Currently open trials in the same condition.
- NCT07341087 — Skin Inflammation in Perimenopause: A Probiotic Intervention Proof of Concept Trial · NA · recruiting
- NCT07474883 — Efficacy of 0.5% Topical Timolol Eye Drops in the Treatment of Post-Inflammatory Erythema Following Acne Vulgaris · EARLY_PHASE1 · recruiting
- NCT07186413 — A Study to Compare the Efficacy, Safety and Pharmacokinetics of Trifarotene 50 mcg/g Cream in Chinese Subjects With Acne · Phase 3 · recruiting
- NCT07056673 — Cold Atmospheric Plasma for Moderate-to-severe Acne Vulgaris Study · NA · recruiting
- NCT07102186 — Efficacy and Safety of Adapalene Gel and Hyaluronic Acid Versus Adapalene Gel Alone in Mild to Moderate Acne Vulgaris · Phase 4 · recruiting
Other Galderma R&D trials
Trials by the same sponsor.
- NCT07047690 — A Study of Nemolizumab for the Treatment of Adults With Systemic Sclerosis · Phase 2 · recruiting
- NCT07344584 — A Prospective Pilot Study to Evaluate Safety and Effectiveness of GP0122 and GP0124 for Correction of Lines and Wrinkles · NA · not yet recruiting
- NCT07186413 — A Study to Compare the Efficacy, Safety and Pharmacokinetics of Trifarotene 50 mcg/g Cream in Chinese Subjects With Acne · Phase 3 · recruiting
- NCT07398989 — A Clinical Study to Assess Efficacy and Tolerability of a Topical Skincare Product on Adults With Mature, Crepey Skin · Phase 4 · completed
- NCT06988618 — Real-world Experience on Using Nemolizumab in the Treatment of Moderate-to- Severe Prurigo Nodularis in Adults · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02556788 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Galderma R&D
- Last refreshed: 28 October 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02556788.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing