Atopic Dermatitis
Conditions
Keywords
Atopic Dermatitis
Brief summary
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.
Interventions
DRUG0416
Topical 0416 test product applied twice daily for 2 weeks
DRUGVehicle of 0416 test product
Vehicle of 0416 test product applied twice daily for 2 weeks
Reference Product for 0416 test product. Apply twice daily for 2 weeks.
Sponsors
Fougera Pharmaceuticals Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Success Based on the Investigator's Global Evaluation at the End of Treatment | 2 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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). | 2 weeks |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Test Test product that contains the active pharmaceutical ingredient
Tacrolimus Ointment 0.1% test product applied twice daily for 2 weeks | 269 |
| Reference Reference product that contains active pharmaceutical ingredient
Protopic Ointment 0.1%: Reference Product applied twice daily for 2 weeks. | 260 |
| Vehicle Placebo that contains no active pharmaceutical ingredient
Vehicle of Tacrolimus Ointment 0.1% applied twice daily for 2 weeks | 264 |
| Total | 793 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 9 | 3 |
| Overall Study | Lack of Efficacy | 1 | 0 | 1 |
| Overall Study | Lost to Follow-up | 8 | 5 | 7 |
| Overall Study | Protocol Violation | 2 | 1 | 2 |
| Overall Study | Withdrawal by Subject | 9 | 4 | 15 |
Baseline characteristics
| Characteristic | Test | Reference | Vehicle | Total |
|---|---|---|---|---|
| Age, Customized Age | 43.0 years STANDARD_DEVIATION 16.29 | 43.7 years STANDARD_DEVIATION 16.74 | 43.3 years STANDARD_DEVIATION 17.14 | 43.3 years STANDARD_DEVIATION 16.7 |
| Region of Enrollment Central America | 11 participants | 7 participants | 9 participants | 27 participants |
| Region of Enrollment United States | 258 participants | 253 participants | 255 participants | 766 participants |
| Sex: Female, Male Female | 148 Participants | 158 Participants | 161 Participants | 467 Participants |
| Sex: Female, Male Male | 121 Participants | 102 Participants | 103 Participants | 326 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 6 / 269 | 15 / 260 | 8 / 264 |
| serious Total, serious adverse events | 0 / 269 | 0 / 260 | 0 / 264 |
Outcome results
Primary
Incidence of Success Based on the Investigator's Global Evaluation at the End of Treatment
Time frame: 2 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Test | Incidence of Success Based on the Investigator's Global Evaluation at the End of Treatment | 104 participants |
| Reference | Incidence of Success Based on the Investigator's Global Evaluation at the End of Treatment | 121 participants |
| Vehicle | Incidence of Success Based on the Investigator's Global Evaluation at the End of Treatment | 67 participants |
Secondary
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