Phase 3
Completed N=654
Bioequivalence Study of Pimecrolimus Cream, 1% and Elidel® Cream, 1% in Mild to Moderate Atopic Dermatitis
Source: ClinicalTrials.gov NCT03107611 ↗Enrolled (actual)
654
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcomePrimary: Proportion of Modified Intent to Treat Subjects With Success on Investigator's Global Assessment of Disease Severity (Success Being a Score of Clear [0] or Almost Clear [1]) — 108; 115; 98 Participants — p=0.0817
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
To establish the bioequivalence between test drug, Pimecrolimus Cream, 1% with that of reference listed drug, Elidel® (pimecrolimus) Cream 1%, in the treatment of mild to moderate Atopic Dermatitis.
To establish superiority of each active treatment over the placebo.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Modified Intent to Treat Subjects With Success on Investigator's Global Assessment of Disease Severity (Success Being a Score of Clear [0] or Almost Clear [1]) |
108; 115; 98 | 0.0817 |
| PRIMARY Proportion of Per Protocol Subjects With Success on Investigator's Global Assessment of Disease Severity (Success Being a Score of Clear [0] or Almost Clear [1]) |
105; 113; 95 | — |
| SECONDARY Change in Severity of Four Individual Signs and Symptoms |
0; 0; 0; 1; 1; 1 | — |
| SECONDARY Evaluation of Application Site Reactions |
121; 126; 103; 64; 63; 76 | — |
Eligibility Criteria
Inclusion Criteria
- Non-immuno compromised male or female aged 8 years and older
- Clinical diagnosis of mild to moderate Atopic Dermatitis (AD)
- Failed to respond adequately to other topical prescription treatments for AD, or for whom those treatments are not advisable.
- A diagnosis of AD for at least 3 months
- An Investigator's Global Assessment (IGA) of disease severity of mild or moderate at baseline (score of 2 or 3)
- Affected area of AD involvement at least 5% body surface area (BSA)
- Treated with a bland emollient for at least 7 days
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 (e.g., clinically infected atopic dermatitis, impetigo).
- Sunburn, extensive scarring or pigmented lesion(s) in any treatment area at baseline, which would interfere with evaluations
- History or presence of confounding skin conditions, e.g., psoriasis, rosacea, erythroderma, ichthyosis, or scabies.
- History or presence of Netherton's Syndrome, immunological deficiencies or diseases, HIV, diabetes, malignancy, serious active or recurrent infection, clinically significant severe renal insufficiency or severe hepatic disorders
- Concurrent disease or treatment likely to interfere with the study treatment or evaluations
- Known allergy or hypersensitivity to pimecrolimus or any other component of the drug products
- Not willing to minimize or avoid natural and artificial sunlight exposure during treatment
Data sourced from ClinicalTrials.gov (NCT03107611). 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. Informational only — not medical advice.