Phase 2
Completed N=102
Efficacy and Safety Study of CD2027 Ointment 3 Microgram Per Gram (mcg/g) Twice Daily Treatment for Adults With at Least Moderate Atopic Dermatitis
Source: ClinicalTrials.gov NCT00919763 ↗Enrolled (actual)
102
Serious AEs
0.0%
Results posted
May 2012
Primary outcomePrimary: Total Severity Score (TSS) of Target Lesion at Baseline and Week 4 — 7.62; 7.49; 4.7; 4.6 score on a scale
Summary
This was a multi-center, randomized, double-blind, parallel group study. Efficacy Objectives: To evaluate the efficacy of CD2027 ointment 3 mcg/g applied twice daily over 4 weeks versus its vehicle in adult participants with at least moderate atopic dermatitis.
Safety objective: To evaluate safety of CD2027 ointment 3 mcg/g when applied twice daily over 4 weeks versus its vehicle on 5 percent (%) - 20% involved Body Surface Area (BSA) (excluding Head/Neck) in adult participants with at least moderate atopic dermatitis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Severity Score (TSS) of Target Lesion at Baseline and Week 4 |
7.62; 7.49; 4.7; 4.6 | — |
| SECONDARY Change From Baseline in Total Severity Score (TSS) for Individual Signs at Week 4 |
-0.7; -0.7; -0.7; -0.7; -0.8; -0.7 | — |
| SECONDARY Number of Participants With Investigator's Global Assessment (IGA) Score of "0" or "1" and Failure From Baseline of Greater Than 1 Points Over Week 4 |
0; 0; 53; 49; 2; 0 | — |
| SECONDARY Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 1, 2, 3, 4 |
-10.0; -16.2; -21.3; -26.7; -28.7; -33.2 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female participant, 18 years of age or older
- Clinical diagnosis of atopic dermatitis according to Hanifin and Rajka criteria, of at least moderate intensity according to Investigator Global Assessment (IGA greater or equal to 3)
- Body surface affected by the disease between 5% and 20% of total BSA, based on Rule of Nine's, excluding Head/Neck
- At least one area (Target Lesion) which was representative of the participant's disease state, was not located on the hands, feet or genitalia, measures at least 10 cm^2, presented a Total Severity Score of at least 6/15 (total severity score defined as the sum of Erythema, Excoriation, Papulation/Induration, Oozing/Crusting and Lichenification) with oozing/crusting severity at most 1
Exclusion Criteria
- The participant had albumin-adjusted calcium above the upper normal range from screening evaluation
- The participant had history/signs/symptoms suggestive of an abnormality of calcium homeostasis (such as hyperparathyroidism, Paget's disease, adrenal insufficiency, hyperthyroidism)
- The participant had signs/symptoms of urinary stones or has a history of urinary stones within the past 5 years prior to the Screening Visit
Data sourced from ClinicalTrials.gov (NCT00919763). 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.