Phase 2
Completed N=183
LEO 29102 Cream in the Treatment of Atopic Dermatitis
Source: ClinicalTrials.gov NCT01037881 ↗Enrolled (actual)
183
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcomePrimary: Absolute Change in Eczema Area and Severity Index (EASI) Score From Baseline (Last Observation Carried Forward [LOCF]) — -0.85; -2.13; -1.09; -2.86 units on a scale — p=0.27
Summary
This is a proof of concept and dose finding Phase II trial comparing 5 dose strengths with vehicle and an active comparator (Elidel cream 10 mg/g) in a 4 week, twice daily treatment regimen in mild to moderate atopic dermatitis patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Absolute Change in Eczema Area and Severity Index (EASI) Score From Baseline (Last Observation Carried Forward [LOCF]) |
-0.85; -2.13; -1.09; -2.86; -2.41; -2.50 | 0.27 |
| SECONDARY Number of Participants That Were Symptom Free Responders (LOCF) |
6; 2; 5; 9; 10; 13 | — |
| SECONDARY Participants' Assessment of Pruritus on Trunk and Limbs |
5; 1; 4; 7; 5; 7 | — |
| SECONDARY Participants' Overall Assessment of Disease Severity |
2; 1; 2; 3; 4; 1 | — |
| SECONDARY Number of Participants That Were Symptom Free Responders by Visit |
2; 1; 2; 1; 5; 5 | — |
| SECONDARY Absolute Change in Eczema Area and Severity Index (EASI) Score From Baseline by Visit |
-0.09; -1.26; -0.93; -1.43; -1.64; -1.48 | — |
Eligibility Criteria
Inclusion Criteria
- Clinical diagnosis of atopic dermatitis defined according to Hanifin and Rajka
- IGA assessment scored as mild (2) to moderate (3) atopic dermatitis
- Treatment lesions located on the trunk and limbs
- Treatment lesions involving 3% to 10% of the total body surface area
- Patients of either gender between 18 years and 65 years of age
Exclusion Criteria
- Systemic treatment with immunosuppressive drugs or corticosteroids within 6 weeks prior to randomisation
- Topical treatment with immunomodulators (pimecrolimus, tacrolimus) within 2 weeks prior to randomisation
- Topical treatment with corticosteroids from WHO groups II, III or IV within 1 week prior to randomisation
- Use of topical or systemic antibiotics within 2 weeks prior to randomisation
- PUVA or UVB therapy within 4 weeks prior to randomisation
- Clinical infection (viral, fungal or bacterial) on the treatment area
- Known or suspected severe renal insufficiency or severe hepatic disorders
- Patients with history of an immunocompromised disease (e.g., lymphoma, HIV, Wiskott-Aldrich Syndrome)
- Patients with concomitant serious disease (e.g., cancer) which might affect the AD treatment in this trial
- Females who are pregnant or are breast feeding
- Females intending to temporarily or permanently stop their hormonal contraceptive regime during and up to one month post study termination visit
Data sourced from ClinicalTrials.gov (NCT01037881). 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.