Drugs / clobetasol propionate
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clobetasol propionate

Small molecule

Developed for
psoriasis · bullous pemphigoid · cataract · lichen planus, oral · atopic eczema · vulvar lichen sclerosus · alopecia · alopecia areata
+14 more · dermatitis · hand dermatosis · hand-foot syndrome · hyperpigmentation of the skin · osteoarthritis, hand · pemphigus vulgaris · pyogenic granuloma · seborrheic dermatitis · hypertrophic lichen planus · lichen planus · mucous membrane pemphigoid · reactive cutaneous fibrous lesion · Stevens-Johnson syndrome · vitiligo
Investigated by
Galderma R&D · GlaxoSmithKline · LEO Pharma · Salvat · Stiefel, a GSK Company · University Hospital, Rouen
+33 more · Academic and Community Cancer Research United · Actavis Inc. · Amgen · Assistance Publique - Hôpitaux de Paris · Callender Center for Clinical Research · Centre Hospitalier Universitaire, Amiens · Centre for Human Drug Research, Netherlands · Children Hospital and Institute of Child Health, Lahore · Copenhagen University Hospital, Hvidovre · Covance · Damascus University · Dermtreat · First Hospital of China Medical University · Formosa Pharmaceuticals, Inc. · Fundación Eduardo Anitua · Gazi University · Hill Dermaceuticals, Inc. · Mahidol University · Maruho Co., Ltd. · Medical University of Silesia · Medstar Health Research Institute · National Cancer Institute (NCI) · Pernille Pedersen · Proinnovera GmbH · Promius Pharma, LLC · Société de Dermatologie Française · Synteract, Inc. · The Hospital for Sick Children · University Hospital, Montpellier · University of California, San Francisco · University of Palermo · Wyeth is now a wholly owned subsidiary of Pfizer · X-act Cologne Clinical Research GmbH

Regulatory milestones approvals, filings & regulatory actions · 3 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansion US (FDA) OLUX — 2002-12-20 fda.gov ↗
Label expansion US (FDA) TEMOVATE E — 1996-05-03 fda.gov ↗
Approved US (FDA) TEMOVATE — 1985-12-27 fda.gov ↗

Trials 40

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 16 trials
Phase 1 NCT02973776 Dec 2016 → Feb 2017 psoriasis LEO Pharma Completed No outcome recorded
Phase 1 NCT02355639 Jan → Apr 2015 connective tissue disorder LEO Pharma Completed No outcome recorded
Phase 1 NCT01946386 Sep → Oct 2013 psoriasis LEO Pharma Completed No outcome recorded
Phase 1 NCT01381445 Apr → Jul 2011 atopic eczema GlaxoSmithKline Completed No outcome recorded
Phase 1 NCT01043224 Jan → Mar 2010 psoriasis LEO Pharma Completed No outcome recorded
Phase 1 NCT00864240 Oct 2005 — Actavis Inc. Completed No outcome recorded
Phase 1/21 trial
Phase 1/2 NCT03847389 Sep 2019 → May 2020 atopic eczema Hill Dermaceuticals, Inc. Terminated No outcome recorded Stop: Enrollment
Phase 28 trials · 1 met primary
Phase 2 NCT07812701 Sep → Nov 2026 expected osteoarthritis, hand Assistance Publique - Hôpitaux de Paris Not yet recruiting No outcome recorded
Phase 2 NCT07100613 Sep 2024 → Oct 2027 expected lichen planus, oral, mouth mucosa disorder University of Palermo Recruiting No outcome recorded
Phase 2 NCT06363539 Sep 2022 → Mar 2023 pyogenic granuloma Children Hospital and Institute of Child Health, Lahore Completed No outcome recorded
Phase 2 NCT04089735 Aug 2019 → Apr 2020 — Formosa Pharmaceuticals, Inc. Completed No outcome recorded
Phase 2 NCT03592342 Jun 2018 → Dec 2019 lichen planus, oral Dermtreat Completed No outcome recorded
Phase 2 NCT02368886 Mar 2015 → Sep 2017 colon adenocarcinoma, rectum adenocarcinoma Academic and Community Cancer Research United Completed Met primary
Phase 2 NCT02131324 May 2014 → Apr 2016 psoriasis Promius Pharma, LLC Completed No outcome recorded
Phase 2 NCT01567215 May 2012 → Feb 2014 — Pernille Pedersen Completed No outcome recorded
Phase 310 trials · 5 met primary
Phase 3 NCT05724446 Dec 2022 → Dec 2025 overdue cataract Salvat Recruiting No outcome recorded
Phase 3 NCT05364515 Dec 2021 → Feb 2024 vulvar lichen sclerosus Fundación Eduardo Anitua Withdrawn No outcome recorded
Phase 3 NCT04246801 Jun 2020 → May 2021 cataract Salvat Completed No outcome recorded
Phase 3 NCT04249076 Jun 2020 → Apr 2021 cataract Salvat Completed No outcome recorded
Phase 3 NCT02573883 Oct 2015 → Sep 2019 vulvar lichen sclerosus Medstar Health Research Institute Completed Met primary
Phase 3 NCT01235442 Sep 2010 → Oct 2011 psoriasis Amgen Completed Met primary
Phase 3 NCT00862654 Mar 2009 → Feb 2010 seborrheic dermatitis Galderma R&D Completed Met primary
Phase 3 NCT02313870 Jan 2008 → May 2015 bullous pemphigoid University Hospital, Montpellier Completed Met primary
Phase 3 NCT00400725 Sep 2006 → Aug 2007 psoriasis Galderma R&D Completed No outcome recorded
Phase 3 NCT01453686 Aug 2002 → Aug 2003 alopecia areata The Hospital for Sick Children Completed Met primary
Phase 410 trials
Phase 4 NCT03926377 Dec 2020 → Oct 2025 bullous pemphigoid, osteoporosis Centre Hospitalier Universitaire, Amiens Completed No outcome recorded
Phase 4 NCT02733874 Apr 2015 → Apr 2016 psoriasis First Hospital of China Medical University Completed No outcome recorded
Phase 4 NCT02360202 Feb 2015 → Feb 2017 bullous pemphigoid University Hospital, Rouen Completed No outcome recorded
Phase 4 NCT01893567 Jul → Oct 2013 psoriasis Galderma R&D Completed No outcome recorded
Phase 4 NCT01012713 Jun 2010 → Dec 2014 psoriasis University of California, San Francisco Completed No outcome recorded
Phase 4 NCT01111981 Oct 2009 → Feb 2010 alopecia Callender Center for Clinical Research Unknown No outcome recorded
Phase 4 NCT00988637 Oct 2009 → Mar 2010 psoriasis Galderma R&D Completed No outcome recorded
Phase 4 NCT00852761 Mar → Jun 2009 psoriasis Stiefel, a GSK Company Completed No outcome recorded
Phase 4 NCT00828464 Oct 2008 → Jan 2009 hand dermatosis Stiefel, a GSK Company Completed No outcome recorded
Phase 4 NCT00842153 Nov → Dec 2007 psoriasis Stiefel, a GSK Company Completed Mixed
Phase not applicable5 trials
— NCT07278999 Dec 2025 → Oct 2026 expected lichen planus, oral, multiple mucosal neuroma Medical University of Silesia Recruiting No outcome recorded
— NCT07641725 Nov 2025 → Sep 2026 overdue pemphigus vulgaris Damascus University Recruiting No outcome recorded
— NCT06856590 Feb → Sep 2025 hand-foot syndrome Gazi University Completed No outcome recorded
— NCT03779360 Oct 2018 → Feb 2019 dermatitis Centre for Human Drug Research, Netherlands Completed No outcome recorded
— NCT02492373 Feb 2015 → May 2016 hyperpigmentation of the skin, lentigo Mahidol University Completed No outcome recorded
Comparator or background therapy42 trials
Phase 0 NCT07398807 Comparator Aug 2025 → Feb 2026 overdue vitiligo Combined Military Hospital (CMH) institute of Medical Sciences Bahawalpur Pakistan Recruiting No outcome recorded
Phase 0 NCT06555497 Comparator Jan 2022 → Dec 2023 psoriasis Dr. Jose N. Rodriguez Memorial Hospital and Sanitarium Completed No outcome recorded
Phase 1 NCT05885269 Comparator Nov 2022 → Apr 2023 alopecia areata Combined Military Hospital Abbottabad Completed No outcome recorded
Phase 1 NCT03878771 Comparator Mar → Apr 2019 Stevens-Johnson syndrome, mucous membrane pemphigoid, pemphigus vulgaris Beni-Suef University Completed No outcome recorded
Phase 1 NCT03758365 Comparator Nov 2018 vascular disorder MC2 Therapeutics Completed No outcome recorded

News releases announcing trial results or a regulatory action · 16

DateIssuerRelease
2024-11-04 Formosa Pharmaceuticals, Inc. Results Formosa Pharmaceuticals Announces Successful Top-Line Results from CPN-303, a Phase 3 Trial in Chinese Subjects for the Treatment of Inflammation and Pain after Cataract Surgery formosapharma.com ↗
Treatment with an APP13007 eyedrop twice daily for 14 days achieved both primary endpoints by producing rapid and sustained clearance of ocular inflammation and cure of ocular pain which were clinically and statistically superior to placebo.
2024-03-05 Formosa Pharmaceuticals, Inc. Regulatory Formosa Pharmaceuticals and AimMax Therapeutics Receive FDA Approval for Clobetasol Propionate Ophthalmic Suspension 0.05%, for the Treatment of Post-Operative Inflammation and Pain Following Ocular Surgery formosapharma.com ↗
2023-05-05 Formosa Pharmaceuticals, Inc. Regulatory Formosa Pharmaceuticals and AimMax Therapeutics Announce the NDA Submission to the US FDA for APP13007 for the Treatment of Post-Operative Inflammation and Pain following Ocular Surgery formosapharma.com ↗
announce the submission of a New Drug Application to the United States Food & Drug Administration (US FDA) for APP13007
2023-01-31 Formosa Pharmaceuticals, Inc. Results Formosa Pharmaceuticals Announce a Summary of Integrated Clinical Results for APP13007 for the Treatment of Inflammation and Pain after Cataract Surgery formosapharma.com ↗
Formosa Pharmaceuticals, Inc. ( 6838 .TWO) report a summary of integrated clinical results for APP13007, a novel ophthalmic nanosuspension formulation of the potent corticosteroid, clobetasol propionate (0.05%), for the treatment of inflammation and pain after cataract surgery.
2022-08-10 Formosa Pharmaceuticals, Inc. Results Formosa Pharmaceuticals and AimMax Therapeutics Announce Successful Top-Line Results from CPN-302 for the Treatment of Inflammation and Pain after Cataract Surgery. formosapharma.com ↗
Treatment with an APP13007 eyedrop twice daily for 14 days achieved both primary endpoints by producing rapid and sustained clearance of ocular inflammation and cure of ocular pain which were statistically (p<0.001) and clinically superior to placebo.
2022-05-18 Formosa Pharmaceuticals, Inc. Results Formosa Pharmaceuticals and AimMax Therapeutics to Present Phase 2 Trials Results of APP13007 for the Treatment of Inflammation and Pain after Cataract Surgery at The Association for Research in Vision and Ophthalmology (ARVO) 2022 Annual Meeting formosapharma.com ↗
Dr. Jeffrey Levenson, Clinical Investigator, Associate Clinical Instructor of Ophthalmology at the University of Florida, and founding director of Levenson Eye Associates (Jacksonville, FL), will present data showing a statistically-significant and clinically-meaningful improvement of inflammation and pain with twice-daily APP13007 compared to matching placebo, a regimen that is being evaluated in the ongoing Phase 3 studies.
2022-05-12 Formosa Pharmaceuticals, Inc. Results Formosa Pharmaceuticals and AimMax Therapeutics Announce Successful Top-Line Results from CPN-301 for the Treatment of Inflammation and Pain after Cataract Surgery formosapharma.com ↗
Treatment with an APP13007 eyedrop twice daily for 14 days met the two primary endpoints by producing rapid and sustained clearance of ocular inflammation and cure of ocular pain which were statistically and clinically superior to placebo.
2020-05-01 Alembic Pharmaceuticals Ltd. Regulatory 19th May, 2020, Vadodara, India alembicpharmaceuticals.com ↗
Alembic Pharmaceuticals Limited (Alembic) today announced that its joint venture, Aleor Dermaceuticals Limited (Aleor) has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Clobetasol Propionate Shampoo, 0.05%.
2019-10-01 Alembic Pharmaceuticals Ltd. Regulatory 4th October, 2019, Vadodara, India alembicpharmaceuticals.com ↗
Alembic Pharmaceuticals Limited (Alembic) today announced that its joint venture Aleor Dermaceuticals Limited (Aleor) has received approval from. the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Clobetasol Propionate Spray, 0.05%.
2019-01-08 Zydus Lifesciences Limited Regulatory Zydus receives final approval from the USFDA for Clobetasol Propionate Lotion zyduslife.com ↗
Zydus Cadila has received the final approval from the USFDA to market Clobetasol Propionate Lotion, (US RLD - Clobex Lotion ), 0.05%.
2018-11-26 Glenmark Pharmaceuticals Ltd. India Regulatory Glenmark Pharmaceuticals receives tentative ANDA approval for Clobetasol Propionate Foam, 0.05% (Emulsion Formulation) glenmarkpharma.com ↗
Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted tentative approval by the United States Food & Drug Administration (U.S. FDA) for Clobetasol Propionate Foam, 0.05% (Emulsion Formulation), a generic version of Olux-E®1 Foam, 0.05%, of Mylan Pharmaceuticals, Inc.
2018-03-26 Lupin Limited Regulatory Lupin receives FDA approval for generic Clobex® Spray, 0.05% lupin.com ↗
Mumbai, Baltimore: Pharma major Lupin announced that it has received final approval for its Clobetasol Propionate Spray, 0.05% from the United States Food and Drug Administration (FDA) to market a generic version of Galderma Laboratories, L.P.’s Clobex® Spray, 0.05%.

All press releases naming this drug 35 releases

DateIssuerRelease

Evidence & citations 18 cited values

Every value below carries the sentence it was read from. 84 sources stand behind the page.

FieldValueCited text
Known as clobetasol propionate “From D0-D28 a dose of cream (Clobetasol Propionate 0.05%) will be applied twice a day for 2 weeks then once a day for 2 weeks on painful joints with the maximum dose being the...” NCT07812701 ↗
79

“In a study of 1254 subjects treated with clobetasol propionate spray 0.05% as monotherapy twice daily for four weeks, 35.7% of patients achieved clearance and 37.3% of patients...” NCT01012713 ↗

“The primary objective of this study was to compare the therapeutic efficacy of clobetasol propionate 0.05% oral gel versus an anti-inflammatory mouthwash in an oral solution...” NCT04673916 ↗

“the patients will be randomly treated with azathioprine 300 mg per week or azathioprine 100 mg a day orally along with topical clobetasol propionate 0.05% w/w and oral...” NCT00189397 ↗

“Application of betamethasone valerate 0.1% (Betneval 0.1% cream), a potent topical corticosteroid, and if not active, application of clobetasol propionate 0.05% (Dermoval 0.05%...” NCT03983460 ↗

“The test shampoo, Clobetasol propionate Shampoo 0.05% (marketed in the USA under the tradename of Clobex®) was developed to provide the strongest available corticosteroid as a...” NCT00438399 ↗

“Clobetasol propionate 0.05% (Clobederm) is applied topically to oral lichen planus lesions twice daily for a period of 5 weeks, according to standard clinical practice.” NCT07536737 ↗

“DFD06 Cream vs Clobetasol Propionate Cream, 0.05% Hypothalamic- Pituitary-Adrenal (HPA) Axis Suppression Study in Patients With Moderate to Severe Plaque Psoriasis” NCT02131324 ↗

“A Double Blind Phase II Study Comparing Safety and Efficacy of Tacrolimus Versus Topical Clobetasol Propionate in the Treatment of Vulvar Lichen Sclerosus.” NCT00757874 ↗

“This study is being conducted to obtain efficacy and tolerability data for two clobetasol propionate therapies in the treatment of plaque-type psoriasis.” NCT00852761 ↗

“Subject Reported Target-lesion Numeric Rating Scale Evaluation by Subjects With Plaque Psoriasis Treated With Clobex® (Clobetasol Propionate) Spray 0.05%” NCT01893567 ↗

Show 69 more sources

Known as Clobederm “Clobetasol propionate 0.05% (Clobederm) is applied topically to oral lichen planus lesions twice daily for a period of 5 weeks, according to standard clinical practice.” NCT07536737 ↗
Known as clobetasol “OBJECTIVE: To assess the effect of clobetasol propionate ophthalmic nanoemulsion, 0.05% (clobetasol) on ocular inflammation and eye pain associated with cataract surgery.” PMID 42192627 ↗ May 2026
1

“Clobetasol, a high-potency corticosteroid, has been shown to significantly reduce the severity of HFSR when used preemptively rather than reactively.” NCT06856590 ↗

Known as Clobetasol 17-propionate ClinicalTrials.gov intervention name — accepted as the source's own label NCT05706870 ↗
Known as Clobex “The test shampoo, Clobetasol propionate Shampoo 0.05% (marketed in the USA under the tradename of Clobex®) was developed to provide the strongest available corticosteroid as a...” NCT00438399 ↗
2

“Subject Reported Target-lesion Numeric Rating Scale Evaluation by Subjects With Plaque Psoriasis Treated With Clobex® (Clobetasol Propionate) Spray 0.05%” NCT01893567 ↗

“Vectical™ (Calcitriol) Ointment 3 µg/g and Clobex® (Clobetasol Propionate) Spray, 0.05%” NCT00988637 ↗

Known as Clobex Shampoo “Clobex® shampoo (Clobetasol Propionate) 0.05 percent (%) weight by weight (W/W) topically to the scalp once daily (twice a week) for 4 weeks” NCT00400725 ↗
Known as Clobex TM “To determine the dose-response relationship for Clobex TM (clobetasol propionate) Lotion, 0.05%.” NCT00864240 ↗
Known as CPN “To evaluate clobetasol propionate ophthalmic suspension (CPN) as treatment for inflammation and pain after cataract surgery.” PMID 41329923 ↗ May 2026
Known as Dermoval “Clobetasol propionate (Dermoval® 0,05% cream), administered for 6 months.” NCT03926377 ↗
1

“Dermoval®/Dermovate® (clobetasol propionate 0.05%) cream” NCT02973776 ↗

Known as Dermoval 0.05% cream “Application of betamethasone valerate 0.1% (Betneval 0.1% cream), a potent topical corticosteroid, and if not active, application of clobetasol propionate 0.05% (Dermoval 0.05%...” NCT03983460 ↗
Known as Dermovate “Dermovate creme group IV steroid. Application 2 times a day for 3 weeks or less if the granuloma disappears.” NCT01567215 ↗
3

“Dermoval®/Dermovate® (clobetasol propionate 0.05%) cream” NCT02973776 ↗

“Clobetasol Propionate 0.05% Cream (Dermovate)” NCT07240389 ↗

NCT01946386 ↗

Known as Dermovate cream “Clobetasol propionate 0.05%(Dermovate cream) in orabase” NCT03878771 ↗
Known as Olux-E “Clobetasol propionate foam 0.05% (Olux-E), a Class 1 corticosteroid, is formulated in an ethanol free petrolatum base that provides the benefits of a super-potent...” NCT01323673 ↗
1

“Olux-E (clobetasol propionate 0.05%) foam.” NCT00852761 ↗

Known as Propionate clobetasol “Patients will be treated with Propionate clobetasol gel 0.05% for 30 consecutive days.” NCT03320460 ↗
Known as Rivelin-CLO patches “Randomized, double-blind, placebo-controlled, parallel group clinical study with 3 active dose arms (Rivelin®-CLO patches) and one placebo arm (Rivelin® plain patch).” NCT03592342 ↗
Action Inhibit “This results in synthesis of certain anti-inflammatory proteins, while inhibiting the synthesis of certain inflammatory mediators.” NCT03779360 ↗
Modality Small molecule “two different forms of a topical steroid (clobetasol propionate)” NCT00852761 ↗
Route Topical “topical clobetasol propionate 0.05% w/w” NCT00189397 ↗