Study of 0417 Ointment in the Treatment of Atopic Dermatitis

Fougera Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Atopic Dermatitis

Treatments: Drug: Tacrolimus Ointment 0.03%; Drug: 0417; Drug: Vehicle of 0417 test product

Study type: Interventional

Funder types: Industry

Identifiers

NCT01139450

0417

Details and patient eligibility

About

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.

Enrollment: 899 patients

Sex: All

Ages: 8+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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899 participants in 3 patient groups, including a placebo group

Test

Experimental group

Description:

Test product that contains the active pharmaceutical ingredient

Treatment:

Drug: 0417

Reference

Active Comparator group

Description:

Reference product that contains the active pharmaceutical ingredient

Treatment:

Drug: Tacrolimus Ointment 0.03%

Vehicle

Placebo Comparator group

Description:

Placebo that contains no active pharmaceutical ingredient

Treatment:

Drug: Vehicle of 0417 test product