A Phase 2, proof of concept and dose finding study, investigating treatment efficacy of LEO 29102 cream (2.5 mg/g, 1.0 mg/g, 0.3 mg/g, 0.1 mg/g, 0.03 mg/g), LEO 29102 cream vehicle, and Elidel (Pimecrolimus) cream 10 mg/g, after cutaneous administration twice daily for 4 weeks.An international, multi-centre, prospective, randomised, double-blind, 7 arm, vehicle-controlled, parallel group study - LEO 29102 Cream in the Treatment of Atopic Dermatitis

• Conditions: Diagnosis of atopic dermatitis graded as mild to moderate according to the Rajka and Langeland system.; MedDRA version: 12.0Level: LLTClassification code 10003639Term: Atopic dermatitis

• Registration Number: EUCTR2009-013792-22-FI
• Lead Sponsor: EO Pharma A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10-08
• Last Update Posted: 18 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 175

Inclusion Criteria

1. Clinical diagnosis of atopic dermatitis defined
according to Hanifin and Rajka.
2. IGA assessment scored as mild (2) to moderate (3)
atopic dermatitis.
3. Treatment lesions located on the trunk and/or limbs.
4. Treatment lesions involving 3% to 10% of the total
body surface area.
5. Patients of either gender between 18 years and 65
years of age.
6. Female patients on:
- hormonal contraceptives (used as a pill, patch,
ring and implant or as an injection) for at least
one menstrual cycle prior to randomisation:
* combined contraceptives containing both an
estrogen and a progestin
* progestogen-only contraceptives containing
only progesterone or a synthetic analogue
(progestin)
- intra uterine devices which are combined with a
hormone for at least one menstrual cycle prior to
randomisation
in Germany, contraceptive regimens must have been
used for at least 12 weeks before Visit 1, and the
patients must agree to continue their contraception
during the trial and for 1 month after the last application
of an investigational product in this trial.
7. Following verbal and written information about the
trial, the patient must provide signed and dated informed
consent before any study related activity is
carried out, including activities relating to the washout
period.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Systemic treatment with immunosuppressive drugs
(e.g., methotrexate, cyclosporine, azathioprine) or
corticosteroids within 6 weeks prior to randomisa-
tion. (Inhaled or in-tranasal steroids corresponding to
doses up to 1 mg prednisone may be used).
2. Topical treatment with immunomodulators (pimecrolimus,
tacrolimus) within 2 weeks prior to randomisation.
3. Topical treatment with corticosteroids from WHO
groups II, III or IV within 1 week prior to randomisation.
4. Use of topical or systemic antibiotics within 2 weeks
prior to randomisation.
5. Other topical therapy on the treatment areas areas within 1
week prior to randomisation. Note: use of emollient is
permitted on AD lesion during a washout period only
and on body areas not to be treated with investigational
product. Use of hydrocortisone cream 1% is permitted
on AD lesions on the face, neck and hands.
6. Change in systemic anti-histamine therapy within
two weeks prior to randomisation, i.e., the patients
should not start anti-histamine treatment or change
current dosage regimen within two weeks prior to
randomisation.
7. PUVA or UVB therapy within 4 weeks prior to
randomisation.
8. Clinical infection (viral, fungal or bacterial) on the
treatment area.
9. Known or suspected severe renal insufficiency or
severe hepatic disorders.
10. Patients with history of an immunocompromised
disease (e.g., lymphoma, HIV, Wiskott-Aldrich Syndrome).
11. Patients with concomitant serious disease (e.g.,
cancer) which might affect the AD treatment in this
trial.
12. Planned extensive sun exposure of treatment areas
during trial participation (e.g., sun bathing, use of
solarium, etc.).
13. Known or suspected hypersensitivity to component(
s) of the investigational product or comparator
(Elidel® cream (pimecrolimus) 10 mg/g).
14. Females who are pregnant or are breast feeding.
15. Females intending to temporarily or permanently
stop their hormonal contraceptive regime during and
up to one month post study termination Visit.
16. Current or within 4 weeks participation in any other
interventional clinical trial.
17. Previously randomised in this study.
18. In the opinion of the Investigator unlikely to comply
with the Clinical Study Protocol.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified