Study of 0416 Ointment in the Treatment of Atopic Dermatitis

Fougera Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Atopic Dermatitis

Treatments: Drug: 0416; Drug: Vehicle of 0416 test product; Drug: tacrolimus ointment 0.1%

Study type: Interventional

Funder types: Industry

Identifiers

NCT01053247

0416

Details and patient eligibility

About

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.

Enrollment: 793 patients

Sex: All

Ages: 18+ 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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793 participants in 3 patient groups, including a placebo group

Test

Experimental group

Description:

Test product that contains the active pharmaceutical ingredient

Treatment:

Drug: 0416

Reference

Active Comparator group

Description:

Reference product that contains active pharmaceutical ingredient

Treatment:

Drug: tacrolimus ointment 0.1%

Vehicle

Placebo Comparator group

Description:

Placebo that contains no active pharmaceutical ingredient

Treatment:

Drug: Vehicle of 0416 test product