NCT00703846 is a Phase 4 clinical trial of Ketoconazole in Dermatitis, Seborrheic, sponsored by Stiefel, a GSK Company.

Who is sponsoring NCT00703846?

NCT00703846 is sponsored by Stiefel, a GSK Company.

What drugs are being tested in NCT00703846?

Interventions in NCT00703846: Ketoconazole.

What condition does NCT00703846 study?

NCT00703846 studies Dermatitis, Seborrheic.

Is NCT00703846 still recruiting?

NCT00703846 is currently completed. Last updated 1 December 2016.

Are results published for NCT00703846?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2016-12-01 · How we verify

NCT00703846

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A PHASE 4, OPEN-LABEL STUDY TO ASSESS THE LONG-TERM SAFETY OF EXTINA (KETOCONAZOLE) FOAM, 2% IN THE TREATMENT OF SEBORRHEIC DERMATITIS

Completed Phase 4 Results posted Last updated 1 December 2016

What this trial tests

Phase 4 trial testing Ketoconazole in Dermatitis, Seborrheic in 498 participants. Completed in 1 April 2010.

Timeline

1 June 2008

Primary endpoint
1 April 2010

1 April 2010

Quick facts

Lead sponsor	Stiefel, a GSK Company
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	498
Start date	1 June 2008
Primary completion	1 April 2010
Estimated completion	1 April 2010

Drugs / interventions tested

Ketoconazole (ketoconazole) — full drug profile →

Conditions studied

Dermatitis, Seborrheic — all drugs for Dermatitis, Seborrheic →

Sponsor

Stiefel, a GSK Company — full company profile →

Who can join

12 and older, any sex, with Dermatitis, Seborrheic. 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.

Number of Participants With Any Adverse Event (AE)
Time frame: From baseline through 52 weeks
An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, which does not necessarily have a causal relationship with the treatment. For a list of all adverse events occurring at or above a frequency threshold of 5% during the course of the study, see the table entitled "Other (Non-Serious) Adverse Events."

Sponsor's own description

Extina (ketoconazole) Foam, 2% was approved for marketing in the United States (US) in June 2007. Extina foam is indicated for topical treatment of seborrheic dermatitis in immunocompetent patients 12 years of age and older. The approved dosing regimen is twice daily for 4 weeks. The treatment of recurrent seborrheic dermatitis demands a topical preparation that is safe for both short-term and chronic application. This study is being conducted in order to obtain long-term safety data on the use of Extina (ketoconazole) Foam, 2% in the treatment of seborrheic dermatitis.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Topical antifungals for seborrhoeic dermatitis.
Okokon EO, Verbeek JH, Ruotsalainen JH, Ojo OA, et al · · 2015 · cited 26× · PMID 25933684 · DOI 10.1002/14651858.cd008138.pub3
Topical antifungals for seborrhoeic dermatitis
Okokon E, Verbeek J, Ruotsalainen J, Ojo O, et al · · 2015

Verify or expand the search:

Other trials of Ketoconazole

Trials testing the same drug.

NCT06560086 — Ketoconazole Contributes to Cryptorchidism Outcome Via Modulating Macrophage Trem2 · NA · unknown
NCT04869449 — Neuro-pharmacological Properties of Repurposed Ketoconazole in Glioblastomas · EARLY_PHASE1 · terminated
NCT04212000 — Bioavailability of Levoketoconazole and Ketoconazole Tablets · Phase 1 · completed
NCT03796273 — Ketoconazole Before Surgery in Treating Patients With Recurrent Glioma or Breast Cancer Brain Metastases · EARLY_PHASE1 · terminated
NCT03471364 — Ketoconazole in Treating Participants With Ongoing EGFR Inhibitor-Induced Rash · EARLY_PHASE1 · completed

Other Stiefel, a GSK Company trials

Trials by the same sponsor.

NCT02673619 — A Study to Evaluate Clinical Effect, Pharmacokinetics , Safety, and Tolerability of Umeclidinium in Palmar Hyperhidrosis · Phase 2 · completed
NCT02411162 — A Single Dose Phase I Exploratory Study in Healthy Volunteers With GSK2894512 Cream · Phase 1 · completed
NCT02014584 — Sexual Function in Men Receiving Dutasteride for Androgenetic Alopecia · Phase 3 · completed
NCT01984775 — A Study to Evaluate the Irritation Potential of GSK2894512 Cream on Skin in Healthy Subjects · Phase 1 · completed
NCT01446237 — U0289-405: An Open-Label, 12-Week Study to Evaluate the Efficacy and Safety of the Acne System (Benzoyl Peroxide 2.5%, S · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00703846 (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 Stiefel, a GSK Company
Last refreshed: 1 December 2016

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/NCT00703846.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing