STUDY TO ASSESS THE LONG-TERM SAFETY OF EXTINA (KETOCONAZOLE) FOAM, 2%

NCT00703846 | Completed Phase 4 Results

• 1 other identifier: 114568
• Study Type: interventional
• Target: 498
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Dermatitis, Seborrheic

Keywords

Phase 4; Seborrheic; Ketoconazole; Dermatitis

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Any Adverse Event (AE)

  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."

  From baseline through 52 weeks

Secondary Outcomes (10)

• Mean Change From Baseline in Skin Assessments for Erythema at Weeks 4, 8, 16, 26, 39, and 52 (or Early Termination)

  Baseline and Weeks 4, 8, 16, 26, 39, and 52 (or early termination)

• Mean Change From Baseline in Skin Assessments for Scaling at Weeks 4, 8, 16, 26, 39, and 52 (or Early Termination)

  Baseline and Weeks 4, 8, 16, 26, 39, and 52 (or early termination)

• Mean Change From Baseline in Skin Assessments for Pruritus at Weeks 4, 8, 16, 26, 39, and 52 (or Early Termination)

  Baseline and Weeks 4, 8, 16, 26, 39, and 52 (or early termination)

• Mean Change From Baseline in Investigator's Static Global Assessment (ISGA) at Weeks 4, 8, 16, 26, 39, and 52 (or Early Termination)

  Baseline and Weeks 4, 8, 16, 26, 39, and 52 (or early termination)

• Median Number of Flares

  From baseline through 52 weeks

Study Arms (1)

KETOCONAZOLE

OTHER

Drug: Ketoconazole

Interventions

Ketoconazole DRUG

Foam, 2%, Extina will be applied twice daily (morning and evening) to all seborrheic dermatitis lesions on the face, scalp, ears, neck, and chest. Study product should be applied at the first sign of a seborrheic dermatitis flare, and twice daily applications should continue until the area(s) has cleared. All symptom flares should be treated throughout the 12-month study period.

KETOCONAZOLE

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must fulfill all of the following conditions or characteristics in order to be considered for study enrollment:
• Capable of understanding and willing to provide signed and dated written voluntary informed consent before any protocol-specific procedures are performed. For subjects between the ages of 12 and 17 years, a parent or legal guardian must be capable of understanding and willing to sign informed consent and subject must be capable of understanding and willing to sign an adolescent assent.
• Male or female subjects 12 years of age or older.
• Able to complete the study and to comply with study instructions.
• Female subjects of childbearing potential must have a negative pregnancy test. Sexually active women of childbearing potential participating in the study must use a medically acceptable form of contraception (which includes oral contraception, injectable or implantable methods, or intrauterine devices). Barrier methods of contraception are not acceptable. A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant. Abstinence is considered an appropriate barrier control method.
• Seborrheic dermatitis on the face, scalp, ears, neck, or chest with an ISGA of 2, 3, or 4 at baseline
• Subjects must have a discrete, evaluable target area of at least 0.5 cm2, with a score of 2, 3, or 4 for erythema and scaling on the Seborrheic Dermatitis Grading Scale

You may not qualify if:

• Subjects with any of the following conditions or characteristics will be excluded from study enrollment:
• Use of systemic antifungal agents, corticosteroids or other immunosuppressive therapies, or systemic retinoids within 4 weeks prior to the baseline visit.
• Use of topical antifungal therapy, corticosteroid therapy, or calcineurin inhibitors to the face, scalp, ears, neck, or chest within 2 weeks prior to the baseline visit.
• Use of any investigational drugs within 8 weeks prior to the baseline visit, or subjects who are scheduled to receive an investigative drug other than the study product during the period of the study.
• History of known or suspected intolerance to any of the ingredients of the study product.
• Female subjects who are pregnant, trying to become pregnant, or lactating.
• Any clinically relevant abnormal vital signs or findings on the physical examination.
• A clinically relevant history of abuse of alcohol or other drugs.
• Any major illness within 30 days prior to the baseline visit.
• Subjects with any clinically significant condition which would, in the opinion of the investigator, compromise the subject's participation in the study.
• Subjects who are immunocompromised.
• Considered unable or unlikely to attend the necessary visits.
• Employees of Stiefel Laboratories or a contract research organization involved in the study, or an immediate family member (partner, offspring, parents, siblings, or sibling's offspring) of an employee.
• Currently using any medication, which in the opinion of the investigator may affect the evaluation of the study product or place the subject at undue risk.

Sponsors & Collaborators

• Stiefel, a GSK Company: lead
• GlaxoSmithKline: collaborator

Related Publications (1)

• Draelos ZD, Feldman SR, Butners V, Alio Saenz AB. Long-term safety of ketoconazole foam, 2% in the treatment of seborrheic dermatitis: results of a phase IV, open-label study. J Drugs Dermatol. 2013 Jan;12(1):e1-6.

  PMID: 23377341 DERIVED

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Dermatitis, Seborrheic; Dermatitis

Interventions

Ketoconazole

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases; Skin Diseases, Eczematous; Skin Diseases, Papulosquamous

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2008
• First Posted: June 24, 2008
• Study Start: June 1, 2008
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: January 30, 2017
• Results First Posted: February 23, 2012

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will share