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Study of 0416 Ointment in the Treatment of Atopic Dermatitis

F

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

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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