Phase 3
N=326
Efficacy and Safety of IDP-124 Lotion for the Treatment of Moderate to Severe Atopic Dermatitis in Pediatric and Adult Subjects
Atopic Dermatitis
Bottom Line
View on ClinicalTrials.gov: NCT03058783 ↗Enrolled (actual)
326
Serious AEs
0.6%
Results posted
May 2023
Primary outcome: Primary: Percentage of Participants Who Had at Least a 2-grade Reduction From Baseline at Week 6 in the Investigator Global Assessment (IGA) Scale and Had an IGA at Week 6 That Equated to "Clear" or "Almost Clear" — 42.04; 32.73 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- IDP-124 Lotion (Drug); IDP-124 Vehicle Lotion (Drug)
- Age
- Pediatric, Adult, Older Adult · 2+ yrs
- Sex
- All
- Sponsor
- Bausch Health Americas, Inc.
- Primary completion
- May 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Had at Least a 2-grade Reduction From Baseline at Week 6 in the Investigator Global Assessment (IGA) Scale and Had an IGA at Week 6 That Equated to "Clear" or "Almost Clear" |
42.04; 32.73 | — |
| SECONDARY Percentage of Participants Who Had at Least a 2-grade Reduction From Baseline in the Investigator Global Assessment (IGA) Scale and Had an IGA That Equated to "Clear" or "Almost Clear" |
18.89; 8.73; 28.70; 24.91; 31.67; 29.64 | — |
| SECONDARY Percentage of Participants Who Had Eczema Area Severity Index (EASI) 75 |
33.61; 26.18; 46.11; 37.45; 43.24; 34.00 | — |
| SECONDARY Percentage of Participants Who Had at Least a 1 Grade Improvement From Baseline in the Severity of Pruritus Score and a Pruritus Score Equating to "None" or "Mild" |
46.19; 37.41; 52.76; 39.81 | — |
Summary
Efficacy and Safety of IDP-124 Lotion for the Treatment of Moderate to Severe Atopic Dermatitis in Pediatric and Adult Subjects
Eligibility Criteria
Inclusion 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 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
- 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
Exclusion Criteria
- Females who are pregnant, breast feeding, or who wish to become pregnant during the study period
- Active cutaneous bacterial or viral infection in any treatment area at Baseline (eg, clinically infected AD)
- Sunburn, extensive scarring, or pigmented lesion(s) in any treatment area at Baseline, which would interfere with evaluations
- History of confounding skin conditions, eg, psoriasis, rosacea, erythroderma, or ichthyosis (other than ichthyosis vulgaris)
- History or presence of:
- basal cell carcinoma of skin effectively treated more than 2 years ago
- carcinoma of cervix effectively treated more than 5 years ago
- immunological deficiencies or diseases, HIV, or serious recurrent infection
- clinically significant severe renal insufficiency or severe hepatic disorders
- Current or recent serious infection
Data sourced from ClinicalTrials.gov (NCT03058783). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.