Study of 0417 Ointment in the Treatment of Atopic Dermatitis

NCT01139450 | Completed Phase 3 Results

• 1 other identifier: 0417
• Study Type: interventional
• Target: 899
• Locations: 1 country
• Sites: 1

Brief 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.

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

  4 weeks

Secondary Outcomes (3)

• The Mean Change From Baseline in the Total Individual Clinical Signs and Symptoms Per Body Region

  Baseline, 4 weeks

• The Mean Change From Baseline in Pruritus

  Baseline, 4 weeks

• The Mean Change From Baseline in the Percentage Total Body Surface Affected (%BSA)

  Baseline, 4 weeks

Study Arms (3)

Test

EXPERIMENTAL

Test product that contains the active pharmaceutical ingredient

Drug: 0417

Reference

ACTIVE COMPARATOR

Reference product that contains the active pharmaceutical ingredient

Drug: Tacrolimus Ointment 0.03%

Vehicle

PLACEBO COMPARATOR

Placebo that contains no active pharmaceutical ingredient

Drug: Vehicle of 0417 test product

Interventions

0417 DRUG

Topical 0417 test product applied twice daily for 4 weeks

Test

Vehicle of 0417 test product DRUG

Vehicle of 0417 test product applied twice daily for 4 weeks

Vehicle

Tacrolimus Ointment 0.03% DRUG

Reference product for 0417 test product. Apply twice daily for 4 weeks

Reference

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), 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

Interventions

SIM0417

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

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: June 7, 2010
• First Posted: June 8, 2010
• Study Start: January 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: October 9, 2014
• Results First Posted: September 30, 2014

Record last verified: 2014-09

Locations

US (1)