Study of 0417 Ointment in the Treatment of Atopic Dermatitis

Atopic Dermatitis Clinical Trial

Official title:

Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel Group Study of 0417 Ointment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01139450
• Other study ID #: 0417
• Status: Completed
• Phase: Phase 3
• First received: June 7, 2010
• Last updated: September 30, 2014
• Start date: January 2008
• Est. completion date: August 2009

Study information

• Verified date: September 2014
• Source: Fougera Pharmaceuticals Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardEcuador: Public Health MinistryPanama: Ministry of HealthDominican Republic: Consejo Nacional de Bioetica en Salud
• Study type: Interventional

Clinical Trial Summary

The aim of this trial is to assess the efficacy of 0417 Ointment in the Treatment of Atopic Dermatitis.

Treatment medication will be administered as follows: Apply a thin layer of ointment to affected skin areas twice daily and rub in gently and completely. Study medication will be applied twice a day, approximately 12 hours apart, for approximately 4 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 899
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of Atopic Dermatitis

• Good health with the exception of Atopic Dermatitis

• Percent Body Surface Area minimum requirements

Exclusion Criteria:

• Subjects who are pregnant, nursing, or planning a pregnancy within the study participation period.

• Subjects who have any systemic or dermatological disorders with the exception of Atopic Dermatitis

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• 0417
Topical 0417 test product applied twice daily for 4 weeks
• Vehicle of 0417 test product
Vehicle of 0417 test product applied twice daily for 4 weeks
• Tacrolimus Ointment 0.03%
Reference product for 0417 test product. Apply twice daily for 4 weeks

Locations

Country	Name	City	State
United States	Fougera Pharmaceuticals Inc.	Melville	New York

Sponsors (1)

Lead Sponsor	Collaborator
Fougera Pharmaceuticals Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Success Based on the Investigator's Global Evaluation at the End of Treatment		4 weeks	No
Secondary	The Mean Change From Baseline in the Total Individual Clinical Signs and Symptoms Per Body Region		Baseline, 4 weeks	No
Secondary	The Mean Change From Baseline in Pruritus		Baseline, 4 weeks	No
Secondary	The Mean Change From Baseline in the Percentage Total Body Surface Affected (%BSA)		Baseline, 4 weeks	No