(Valeant, 12 Weeks)
A Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Study to Evaluate the Efficacy and Safety of IDP-124 Lotion for the Treatment of Moderate to Severe Atopic Dermatitis in Pediatric and Adult Subjects
Minimum Age: 2 Years Old
Maximum Age: N/A
Facility Type: Outpatient
Stipend Range: $50-$100 per visit
Study Length: 12 Weeks
This is a multicenter, randomized, double-blind, parallel group, vehicle-controlled study to evaluate treatment success using a 5-point Investigator Global Assessment (IGA) scale from clear to severe; the improvement of Eczema Area Severity Index (EASI); improvement in total affected body surface area (TBSA); assessment of pruritus (itching) and sleep disturbance; Patient-Oriented Eczema Measure (POEM) from subjects and parents/legal guardians of pediatric subjects; and investigator’s assessment of signs and symptoms of AD.
The study consists of a 6-week double-blind treatment period and 4-week post-treatment follow-up. Study visits include Screening, Baseline, and Weeks 1, 2, 4, 6, and 10 (subjects will return to the clinic at Week 10 for a post-treatment follow-up visit).
Inclusion and Exclusion Criteria
- Male or female at least 2 years of age and older.
- Written and verbal informed consent must be obtained; subjects less than age of consent must sign an assent (as required per IRB/IEC guidelines) for the study and a parent or a legal guardian must sign the informed consent (if subject reaches age of consent during the study they should be re-consented at the next study visit).
- Nonimmunocompromized male or female who failed to respond adequately to other topical prescription treatment for AD or for whom those treatments are not advisable.
- Clear diagnosis of AD fulfilling the diagnostic criteria of Hanifin and Rajka13 that affects ≥ 5% of TBSA (see Appendix 17.4 for full list of diagnostic criteria to reference); subject should have had a diagnosis of AD for at least 3 months; ie, determined by subject-reported or parent-reported duration of subject experiencing itchy and dry skin for 3 months or longer (at Screening and Baseline visits).
- Subject must have a score of 3 (moderate) or 4 (severe) on the IGA scale at the Screening and Baseline visits.
- Subjects must be willing to comply with study instructions and return to the clinic for required visits; subjects under the age of consent must be accompanied by the parent or legal guardian at the time of assent/consent signing.
Other Trial Details
- Physical exam and assessments of study condition to be provided at no cost by an experienced provider.
- No insurance necessary.
- Compensation will be provided for time and travel for all study visits