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Completed

NCT Number: NCT01053247

Study of 0416 Ointment in the Treatment of Atopic Dermatitis

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Fougera Pharmaceuticals Inc.

Melville, New York, 11747, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

0416

Drug

Topical 0416 test product applied twice daily for 2 weeks

Vehicle of 0416 test product

Drug

Vehicle of 0416 test product applied twice daily for 2 weeks

Tacrolimus Ointment 0.1%

Drug

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

Primary outcomes

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

    Time frame: 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).

    Time frame: 2 weeks

Sponsors and collaborators

Lead sponsor

Fougera Pharmaceuticals Inc.

Industry

Registry information

Official study title

Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel Group Study of 0416 Ointment.

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jan 21, 2010
Registry last updated
Oct 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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