A Phase 3 interventional study of Adapalene 0.3% / BPO 2.5% gel in Acne Vulgaris, sponsored by Galderma R&D. Completed at 3 sites in 3 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2021-02-18.
Sponsored by Galderma R&D (part of Galderma Group AG) · Phase 3, Interventional, and Treatment
Among 30 studies testing adapalene in Acne Vulgaris — none open to participants now, 2 under way, none of them phase 3. Adapalene · Acne Vulgaris.
Among the 30 studies testing adapalene in Acne Vulgaris, this one is the 25th largest by enrollment, is the only one that started in 2017, is one of 9 in phase 3, and was the 22nd registered.
790 studies on the registry are indexed under Acne Vulgaris; 93 are open to participants now.
This study's enrollment of 50 is below the median of 70 across 672 interventional studies indexed under Acne Vulgaris.
Browse Acne Vulgaris studies →None of the 30 studies testing adapalene in Acne Vulgaris is open now.
Adapalene: first FDA approval 1996 (DIFFERIN). What it is approved for, and how studies give it, is on its page →
Of the 47 Acne Vulgaris studies recruiting now, 17 (36%) set no upper age limit and 29 (62%) stop at 75 or younger; 21 take children under 18; 17 take healthy volunteers.
This study: 12 Years and older · all sexes · no healthy volunteers.
The full table on the hub →30 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 1 started in 2017.
Median enrollment 215 across the 30 interventional studies. Of the 26 that completed or were terminated, 16 (62%) have results posted.
25 of 30 have an industry lead sponsor. The 10 most frequent:
Galderma R&D is the lead sponsor of 284 studies on the registry; 11 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 55 (92%) have results posted.
45 studies in Acne Vulgaris by Galderma R&D: none open now, 1 under way, 1 of them phase 3. Of 44 finished, 39 (89%) have results posted.
Among the 45 studies in Acne Vulgaris by Galderma R&D, this one is the 38th largest by enrollment, is the only one that started in 2017, is one of 20 in phase 3, and was the 39th registered.
Galderma R&D’s Acne Vulgaris studies by the year they started, since 2004.
None of the studies under way reaches primary completion within a year.
Among the 30 studies testing adapalene in Acne Vulgaris, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among Galderma R&D’s 45 in Acne Vulgaris:
Nothing recorded among them since 2026-09-25.
This is a multicenter open-label, prospective study in subjects with dark skin from one of the 3 ethnic/race backgrounds: Asian, Latin American and Black/African-American and with moderate to severe acne vulgaris on the face.
All eligible subjects will receive Adapalene 0.3% - BPO 2.5% gel (Epiduo Forte/TactuPump Forte) once daily on whole face.
The purpose of this trial is to evaluate subject reported outcomes with the combination of Adapalene 0.3% - BPO 2.5%, Epiduo Forte / TactuPump Forte gel, after 16 weeks of treatment of moderate to severe acne in dark skin phototypes (IV to VI).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Subject with clinical diagnosis of moderate to severe facial acne vulgaris, defined by:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adapalene 0.3% / BPO 2.5% gel, once daily in the evening
Drug: Adapalene 0.3% / BPO 2.5% gel
Drug page: Adapalene
Epiduo Forte / Tactupump gel to be applied once a daily at bed time on entire face during 16 weeks
Also known as: Epiduo Forte / Tactupump gel
Subject 's Overall Satisfaction With Study Treatment Via a Satisfaction Questionnaire
% of subjects satisfied to very satisfied with study treatment at week 12
Time frame: At week 12
| Milestone | Adapalene / BPO Gel |
|---|---|
| Started | 50 |
| Completed | 42 |
| Not completed | 8 |
| Withdrew: Withdrawal by subject | 3 |
| Withdrew: Lost to follow-up | 4 |
| Withdrew: Pregnancy | 1 |
% of subjects satisfied to very satisfied with study treatment at week 12
| Participants | Adapalene / BPO Gel |
|---|---|
| Subject 's Overall Satisfaction With Study Treatment Via a Satisfaction Questionnaire | 36 |
Collected over Up to 16 Weeks. Non-serious events are listed at a 4% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Adapalene / BPO Gel | 0/50 (0%) | 0/50 (0%) | 9/50 (18%) |
| Event | Adapalene / BPO Gel |
|---|---|
| HeadacheNervous system disorders | 3/50 |
| PyrexiaGeneral disorders | 2/50 |
| Post inflammatory pigmentation changeSkin and subcutaneous tissue disorders | 2/50 |
| PruritusSkin and subcutaneous tissue disorders | 2/50 |
ITT population
| Age, Categorical(Participants) | Adapalene / BPO Gel |
|---|---|
| <=18 years | 21 |
| Between 18 and 65 years | 29 |
| >=65 years | 0 |
| Age, Continuous(years) | Adapalene / BPO Gel |
|---|---|
| Mean | 20.9 ± 6.4 |
| Sex: Female, Male(Participants) | Adapalene / BPO Gel |
|---|---|
| Female | 24 |
| Male | 26 |
| Race/Ethnicity, Customized(Participants) | Adapalene / BPO Gel |
|---|---|
| Asian | 20 |
| Latin American | 13 |
| Black/African-American | 17 |
| Region of Enrollment(participants) | Adapalene / BPO Gel |
|---|---|
| Singapore | 16 |
| United States | 18 |
| Mauritius | 16 |
| Skin phototype(Participants) | Adapalene / BPO Gel |
|---|---|
| Phototype IV | 37 |
| Phototype V | 11 |
| Phototype VI | 2 |
PDFs hosted by the registry, ClinicalTrials.gov.
This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Adapalene