A Phase 3 interventional study of CD5789 (trifarotene) 50µg/g Cream and Placebo Cream in Acne Vulgaris, sponsored by Galderma R&D. Completed at 81 sites in 8 countries. Open to participants aged 9 Years and older. Per ClinicalTrials.gov, last updated 2019-11-12.
Sponsored by Galderma R&D · Phase 3, Interventional, and Treatment
Assessment of the efficacy and safety of CD5789 (Trifarotene) 50µg/g cream applied once daily for 12 weeks in subjects with acne vulgaris.
730 studies on the registry are indexed under Acne Vulgaris; 86 are open to participants now.
This study's enrollment of 1,212 is above the median of 69 across 628 interventional studies indexed under Acne Vulgaris.
Browse Acne Vulgaris studies →Galderma R&D is the lead sponsor of 280 studies on the registry; 9 are open to participants now.
Of its 59 completed or terminated interventional studies of FDA-regulated products, 55 (93%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
CD5789 (trifarotene) 50µg/g Cream
Drug: CD5789 (trifarotene) 50µg/g Cream
Placebo Cream
Drug: Placebo Cream
CD5789 (Trifarotene) 50µg/g cream applied once daily during 12 weeks.
Placebo cream applied once daily during 12 weeks.
Investigator Global Assessment (IGA) Score of 1 (Almost Clear) or 0 (Clear)
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.
Time frame: From Baseline to Week 12
| Milestone | CD5789 (Trifarotene) 50µg/g Cream | Placebo Cream |
|---|---|---|
| Started | 602 | 610 |
| Completed | 558 | 573 |
| Not completed | 44 | 37 |
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.
| Participants | CD5789 (Trifarotene) 50µg/g Cream | Placebo Cream |
|---|---|---|
| Investigator Global Assessment (IGA) Score of 1 (Almost Clear) or 0 (Clear) | 255 | 157 |
Collected over Each participant's adverse events were collected starting at the first visit (screening) until the last visit (Week 12).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CD5789 (Trifarotene) 50µg/g Cream | 0/602 (0%) | 2/602 (0.3%) | 21/602 (3.5%) |
| Placebo Cream | 0/610 (0%) | 4/610 (0.7%) | 5/610 (0.8%) |
| Event | CD5789 (Trifarotene) 50µg/g Cream | Placebo Cream |
|---|---|---|
| Ligament SprainInjury, poisoning and procedural complications | 1/602 | 0/610 |
| Suicide AttemptPsychiatric disorders | 1/602 | 1/610 |
| Major DepressionPsychiatric disorders | 1/602 | 0/610 |
| AsthmaRespiratory, thoracic and mediastinal disorders | 0/602 | 1/610 |
| AppendicitisInfections and infestations | 0/602 | 1/610 |
| SinusitisInfections and infestations | 0/602 | 1/610 |
| Event | CD5789 (Trifarotene) 50µg/g Cream | Placebo Cream |
|---|---|---|
| Application Site IrritationGeneral disorders | 15/602 | 0/610 |
| Application Site PuritisGeneral disorders | 5/602 | 2/610 |
| Application Site PainGeneral disorders | 4/602 | 0/610 |
| Application Site DrynessGeneral disorders | 3/602 | 0/610 |
| SunburnInjury, poisoning and procedural complications | 2/602 | 0/610 |
| Skin IrritationSkin and subcutaneous tissue disorders | 2/602 | 0/610 |
| Drug Administered at Inappropriate SiteInjury, poisoning and procedural complications | 1/602 | 0/610 |
| LymphadenopathyBlood and lymphatic system disorders | 1/602 | 0/610 |
| Eyelid ExfoliationEye disorders | 1/602 | 0/610 |
| Eyelid EdemaEye disorders | 1/602 | 0/610 |
| Age, Categorical(Participants) | CD5789 (Trifarotene) 50µg/g Cream | Placebo Cream | Total |
|---|---|---|---|
| <=18 years | 276 | 294 | 570 |
| Between 18 and 65 years | 326 | 316 | 642 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | CD5789 (Trifarotene) 50µg/g Cream | Placebo Cream | Total |
|---|---|---|---|
| Female | 357 | 338 | 695 |
| Male | 245 | 272 | 517 |
| Ethnicity (NIH/OMB)(Participants) | CD5789 (Trifarotene) 50µg/g Cream | Placebo Cream | Total |
|---|---|---|---|
| Hispanic or Latino | 60 | 62 | 122 |
| Not Hispanic or Latino | 542 | 548 | 1090 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | CD5789 (Trifarotene) 50µg/g Cream | Placebo Cream | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 2 | 3 |
| Asian | 2 | 6 | 8 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| Black or African American | 27 | 42 | 69 |
| White | 565 | 554 | 1119 |
| More than one race | 2 | 2 | 4 |
| Unknown or Not Reported | 5 | 3 | 8 |
| Region of Enrollment(Participants) | CD5789 (Trifarotene) 50µg/g Cream | Placebo Cream | Total |
|---|---|---|---|
| Romania | 64 | 65 | 129 |
| Hungary | 74 | 66 | 140 |
| United States | 124 | 154 | 278 |
| Czechia | 63 | 60 | 123 |
| Ukraine | 71 | 74 | 145 |
| Poland | 92 | 96 | 188 |
| Russia | 100 | 81 | 181 |
| Spain | 14 | 14 | 28 |
| Investigator Global Asssessment(participants) | CD5789 (Trifarotene) 50µg/g Cream | Placebo Cream | Total |
|---|---|---|---|
| Clear | 0 | 0 | 0 |
| Almost Clear | 0 | 0 | 0 |
| Mild | 0 | 0 | 0 |
| Moderate | 602 | 610 | 1212 |
| Severe | 0 | 0 | 0 |
Documents are hosted by the registry — open the source record to download them.
This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Galderma R&D