Study of 0416 Ointment in the Treatment of Atopic Dermatitis

NCT01053247 | Completed Phase 3 Results

• 1 other identifier: 0416
• Study Type: interventional
• Target: 793
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this trial is to assess the efficacy of 0416 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 2 weeks.

Conditions

Atopic Dermatitis

Keywords

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• Incidence of Success Based on the Investigator's Global Evaluation at the End of Treatment

  2 weeks

Secondary Outcomes (1)

• The Mean Change From Baseline in the Total Individual Clinical Signs and Symptoms Per Body Region, the Mean Change From Baseline in Pruritus and Mean Change From Baseline in the Percentage Total Body Surface Affected (%BSA).

  2 weeks

Study Arms (3)

Test

EXPERIMENTAL

Test product that contains the active pharmaceutical ingredient

Drug: 0416

Reference

ACTIVE COMPARATOR

Reference product that contains active pharmaceutical ingredient

Drug: tacrolimus ointment 0.1%

Vehicle

PLACEBO COMPARATOR

Placebo that contains no active pharmaceutical ingredient

Drug: Vehicle of 0416 test product

Interventions

0416 DRUG

Topical 0416 test product applied twice daily for 2 weeks

Test

Vehicle of 0416 test product DRUG

Vehicle of 0416 test product applied twice daily for 2 weeks

Vehicle

tacrolimus ointment 0.1% DRUG

Reference Product for 0416 test product. Apply twice daily for 2 weeks.

Reference

Eligibility Criteria

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

You may qualify if:

• Clinical diagnosis of Atopic Dermatitis
• Good health with the exception of Atopic Dermatitis
• Percent Body Surface Area minimum requirements

You may not qualify if:

• 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

Sponsors & Collaborators

• Fougera Pharmaceuticals Inc.: lead

Study Sites (1)

Fougera Pharmaceuticals Inc.

Melville, New York, 11747, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Angela C. Kaplan
• Organization: Fougera Pharmaceuticals Inc

angela.kaplan@sandoz.com

631-659-2256

Study Officials

• Angela C Kaplan

  Fougera Pharmaceuticals Inc.

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2009
• First Posted: January 21, 2010
• Study Start: January 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: October 3, 2014
• Results First Posted: October 3, 2014

Record last verified: 2014-09

Locations

US (1)