Numerous clinical trials evaluate the therapeutic efficacy of adapalene across conditions such as acne vulgaris, photoaging, senile purpura, atrophic acne scars, and plantar warts. Spanning Early Phase 1 through Phase 4, these studies are sponsored by both commercial entities and academic or medical institutions. The broader research landscape reflects various recruitment statuses, including completed, actively recruiting, terminated, and unknown protocols.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07524946 | RECRUITING | Acne Vulgaris |
Bausch Health Americas, Inc. |
2026-04-01 | PHASE4 |
| NCT07421804 | NOT_YET_RECRUITING | Acne Vulgaris |
Assiut University |
2026-04 | |
| NCT07673094 | NOT_YET_RECRUITING | Acne Vulgaris |
Khyber Teaching Hospital |
2026-08-15 | EARLY_PHASE1 |
| NCT07805655 | RECRUITING | Acne Vulgaris |
Jeisys Medical Inc |
2026-09-15 | |
| NCT07473895 | NOT_YET_RECRUITING | Acne Vulgaris |
Assiut University |
2026-04 | PHASE2 |
| NCT07016360 | RECRUITING | Viral Warts |
Khyber Teaching Hospital |
2025-09-15 | PHASE4 |
| NCT07237763 | ACTIVE_NOT_RECRUITING | Acne |
Cairo University |
2024-01-15 | |
| NCT07102186 | RECRUITING | Acne Vulgaris |
Badr University |
2025-07-21 | PHASE4 |
| NCT07348978 | COMPLETED | Acne Vulgaris |
University of Medicine and Pharmacy at Ho Chi Minh City |
2024-11-01 | |
| NCT05582434 | ACTIVE_NOT_RECRUITING | Acne |
Wake Forest University Health Sciences |
2024-02-15 | EARLY_PHASE1 |
| NCT06775314 | NOT_YET_RECRUITING | Acne Vulgaris |
Dr.dr.Irma Bernadette, SpKK (K) |
2025-03-01 | PHASE3 |
| NCT07015931 | COMPLETED | Acne Vulgaris |
Indonesia University |
2024-11-30 | PHASE1; PHASE2 |
| NCT06141330 | COMPLETED | Acne Vulgaris |
HITEC-Institute of Medical Sciences |
2024-02-24 | |
| NCT06336603 | COMPLETED | Acne Vulgaris |
Sun Pharmaceutical Industries Limited |
2023-11-15 | PHASE4 |
| NCT06673641 | COMPLETED | Acne Vulgaris |
Sun Pharmaceutical Industries, Inc. |
2024-05-13 | PHASE1 |
| NCT05536882 | WITHDRAWN | Molluscum Contagiosum |
University of Oklahoma |
2022-05-18 | PHASE3 |
| NCT05899699 | UNKNOWN | Acne Vulgaris |
Mansoura University |
2023-06-05 | PHASE2 |
| NCT05855629 | UNKNOWN | Acne Vulgaris |
Treatment and Diagnostic Center of Private Enterprise "Asklepiy" |
2022-02-18 | |
| NCT04823845 | WITHDRAWN | Plantar Wart |
University of Louisville |
2022-05-01 | EARLY_PHASE1 |
| NCT05497323 | UNKNOWN | Acne Vulgaris |
Dr.dr.Irma Bernadette, SpKK (K) |
2022-08-01 | PHASE1 |
| NCT04892706 | COMPLETED | Acne Vulgaris |
Bausch Health Americas, Inc. |
2021-06-11 | PHASE2 |
| NCT05216289 | COMPLETED | Acne Vulgaris |
Federal University of São Paulo |
2018-04-01 | PHASE4 |
| NCT03563365 | TERMINATED | Acne Vulgaris |
Yardley Dermatology Associates |
2018-06-04 | PHASE4 |
| NCT04797793 | COMPLETED | Acne Vulgaris |
Sun Pharmaceutical Industries, Inc. |
2020-05-18 | EARLY_PHASE1 |
| NCT04329403 | WITHDRAWN | Acne Vulgaris |
Aurobindo Pharma Ltd |
2020-07 | PHASE3 |
| NCT03866447 | UNKNOWN | Acne Vulgaris |
Assiut University |
2019-10-01 | PHASE4 |
| NCT04104685 | COMPLETED | Acne Vulgaris |
Vyne Therapeutics Inc. |
2019-09-18 | PHASE2 |
| NCT03832647 | COMPLETED | Acne |
Vichy Laboratoires |
2019-02-18 | PHASE4 |
| NCT03615768 | COMPLETED | Acne Vulgaris |
Lee's Pharmaceutical Limited |
2018-08-14 | PHASE3 |
| NCT03650881 | WITHDRAWN | Acne |
NYU Langone Health |
2018-08-07 | |
| NCT05096312 | COMPLETED | Acne Vulgaris |
East Avenue Medical Center, Philippines |
2018-12-21 | PHASE4 |
| NCT03650361 | COMPLETED | Acne Vulgaris |
Aleor Dermaceuticals Limited |
2018-09-17 | PHASE3 |
| NCT03457636 | COMPLETED | Acne |
Derm Research, PLLC |
2018-03-19 | PHASE4 |
| NCT03393494 | COMPLETED | Acne Vulgaris |
Padagis LLC |
2017-12-13 | PHASE3 |
| NCT03573115 | COMPLETED | Acne Vulgaris; Microparticles |
Merete Haedersdal |
2018-01-04 | |
| NCT02932267 | COMPLETED | Acne Vulgaris |
Galderma R&D |
2017-02-02 | PHASE3 |
| NCT02593383 | COMPLETED | Acne |
Lee's Pharmaceutical Limited |
2015-03-01 | PHASE1; PHASE2 |
| NCT02735421 | COMPLETED | Acne Vulgaris; Atrophic Acne Scars |
Galderma R&D |
2016-05-13 | PHASE4 |
| NCT02899000 | COMPLETED | Acne Vulgaris |
Galderma R&D |
2016-07-29 | PHASE4 |
| NCT03626298 | COMPLETED | Acne Vulgaris |
Rumah Sakit Pusat Angkatan Darat Gatot Soebroto |
2016-08-01 | PHASE4 |
| NCT02721173 | COMPLETED | Acne Vulgaris |
All India Institute of Medical Sciences, Bhubaneswar |
2016-04 | PHASE4 |
| NCT03585140 | COMPLETED | Acne Vulgaris; Diet Modification |
Centro Dermatológico Dr. Ladislao de la Pascua |
2016-01-01 | |
| NCT02651220 | COMPLETED | Acne |
Actavis Inc. |
2015-11 | PHASE3 |
| NCT02709902 | COMPLETED | Acne Vulgaris |
Sun Pharmaceutical Industries, Inc. |
2015-09 | PHASE1 |
| NCT01406080 | COMPLETED | Photoaging; Photodamage |
Galderma Brasil Ltda. |
2013-01 | PHASE3 |
| NCT02716090 | WITHDRAWN | Acne Vulgaris |
Ache Laboratorios Farmaceuticos S.A. |
PHASE3 | |
| NCT02620813 | Completed | Acne Vulgaris |
University of California Davis |
2015-10 | Early Phase 1 |
| NCT02442817 | Completed | Schizophrenia |
University of Nevada Reno|Augusta University |
2015-03-02 | Phase 4 |
| NCT02411942 | COMPLETED | Acne Vulgaris |
Sun Pharmaceutical Industries, Inc. |
2014-08 | PHASE1 |
| NCT02249104 | COMPLETED | Acne Vulgaris |
Galderma R&D |
2014-08 | PHASE4 |
| NCT02173054 | COMPLETED | Acne |
Mahidol University |
2014-07 | PHASE3 |
| NCT01951417 | COMPLETED | Acne |
Galderma R&D |
2013-10 | PHASE4 |
| NCT01742637 | COMPLETED | Acne Vulgaris |
Sun Pharmaceutical Industries, Inc. |
2012-10 | PHASE1 |
| NCT01474590 | COMPLETED | Acne |
Galderma R&D |
2011-11 | PHASE3 |
| NCT01425320 | WITHDRAWN | Acne Vulgaris |
Allergan |
2013-01 | PHASE1 |
| NCT01485367 | UNKNOWN | Senile Purpura |
Multispecialty Aesthetic Clinical Research Organization |
2011-12 | PHASE2 |
| NCT01504204 | COMPLETED | Acne Vulgaris |
Wake Forest University |
2011-12 | PHASE4 |
| NCT02525549 | COMPLETED | Acne |
Padagis LLC |
2011-12 | PHASE3 |
| NCT01522456 | COMPLETED | Acne Vulgaris |
Galderma R&D |
2012-04 | PHASE4 |
| NCT01213199 | COMPLETED | Acne Scars |
Galderma R&D |
2011-03 | PHASE2 |
| NCT01485367 | Unknown status | Senile Purpura |
Multispecialty Aesthetic Clinical Research Organization|Galderma R&D |
2011-12 | Phase 2 |
| NCT01501799 | COMPLETED | Acne Vulgaris |
Actavis Mid-Atlantic LLC |
2011-07 | |
| NCT01138735 | COMPLETED | Acne |
Galderma R&D |
2010-06 | PHASE4 |
| NCT01231334 | COMPLETED | Acne Vulgaris |
Allergan |
2010-08 | PHASE4 |
| NCT01245946 | COMPLETED | Acne |
Pontificia Universidad Catolica de Chile |
2010-10 | PHASE2 |
| NCT01149330 | COMPLETED | Acne Vulgaris |
Galderma Brasil Ltda. |
2010-07 | PHASE4 |
| NCT01209949 | COMPLETED | Acne Vulgaris |
Galderma R&D |
2010-10 | PHASE4 |
| NCT01106807 | COMPLETED | Acne |
Galderma R&D |
2010-04 | PHASE2 |
| NCT01014689 | COMPLETED | Acne Vulgaris |
Galderma R&D |
2009-08 | PHASE3 |
| NCT01046565 | COMPLETED | Skin Manifestations |
Galderma R&D |
2010-01 | PHASE1 |
| NCT01046396 | COMPLETED | Skin Manifestations |
Galderma R&D |
2010-01 | PHASE1 |
| NCT00647556 | COMPLETED | Photoaging |
Galderma R&D |
2008-04 | PHASE3 |
| NCT01095640 | COMPLETED | Acne Vulgaris |
Actavis Mid-Atlantic LLC |
2009-03 | |
| NCT00964223 | COMPLETED | Acne Vulgaris |
Stiefel, a GSK Company |
2009-07 | PHASE4 |
| NCT00952523 | COMPLETED | Acne Vulgaris |
Bausch Health Americas, Inc. |
2009-07 | PHASE4 |
| NCT00883233 | COMPLETED | Acne |
Galderma R&D |
2009-04 | PHASE3 |
| NCT00687908 | COMPLETED | Acne |
Galderma R&D |
2008-11 | PHASE3 |
| NCT00907101 | COMPLETED | P Acnes Colonization |
Galderma R&D |
2009-06 | PHASE4 |
| NCT00887484 | COMPLETED | Acne Vulgaris |
Stiefel, a GSK Company |
2009-02 | PHASE4 |
| NCT00926367 | COMPLETED | Acne Vulgaris |
Stiefel, a GSK Company |
2009-05 | PHASE4 |
| NCT00919191 | COMPLETED | Acne Vulgaris |
Bausch Health Americas, Inc. |
2009-04 | PHASE4 |
| NCT00688064 | COMPLETED | Severe Acne Vulgaris |
Galderma R&D |
2008-08 | PHASE3 |
| NCT00599521 | COMPLETED | Acne Vulgaris |
Galderma R&D |
2007-11 | PHASE3 |
| NCT00598832 | COMPLETED | Acne Vulgaris |
Galderma R&D |
2007-11 | PHASE3 |
| NCT00829049 | TERMINATED | Acne Vulgaris |
Allergan |
2007-10 | PHASE4 |
| NCT00660985 | COMPLETED | Acne Vulgaris |
Galderma R&D |
2008-05 | PHASE4 |
| NCT00671749 | COMPLETED | Acne Vulgaris |
Galderma R&D |
2007-12 | PHASE4 |
| NCT01182636 | COMPLETED | Acne Vulgaris |
Teva Pharmaceuticals USA |
2007-07 | PHASE1 |
| NCT00714714 | COMPLETED | Acne Vulgaris |
Bausch Health Americas, Inc. |
2008-01 | PHASE4 |
| NCT00421993 | COMPLETED | Acne Vulgaris |
Galderma R&D |
2006-10 | PHASE3 |
| NCT00441415 | COMPLETED | Acne Vulgaris |
Galderma R&D |
2007-02 | PHASE3 |
| NCT00422240 | COMPLETED | Acne Vulgaris |
Galderma R&D |
2006-06-27 | PHASE3 |
| NCT00696449 | COMPLETED | Acne Vulgaris |
Wake Forest University |
2006-06 | PHASE4 |
| NCT00719121 | COMPLETED | Cutaneous Inflammation |
Stiefel, a GSK Company |
2006-11 | PHASE1 |
| NCT00469755 | COMPLETED | Acne Vulgaris |
Galderma R&D |
2006-02 | PHASE4 |
| NCT00151541 | COMPLETED | Acne Vulgaris |
Allergan |
2005-02 | PHASE3 |
| NCT00446043 | COMPLETED | Acne Vulgaris |
Galderma R&D |
2004-02-17 | PHASE3 |
(data from https://clinicaltrials.gov, updated on 2026-07-29)
Check the
Adapalene
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
Note: Technical data last updated: Sep 1, 2026.