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LEO 29102 Cream in the Treatment of Atopic Dermatitis

LEO Pharma logo

LEO Pharma

Status and phase

Completed
Phase 2

Conditions

Atopic Dermatitis

Treatments

Drug: LEO 29102
Drug: Elidel®

Study type

Interventional

Funder types

Industry

Identifiers

NCT01037881
EudraCT Number 2009-013792-22 (Registry Identifier)
LEO 29102-C21

Details and patient eligibility

About

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.

Enrollment

183 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

183 participants in 7 patient groups, including a placebo group

LEO 29102 0.03 mg/g cream
Experimental group
Treatment:
Drug: LEO 29102
LEO 29102 0.1 mg/g cream
Experimental group
Treatment:
Drug: LEO 29102
LEO 29102 0.3 mg/g cream
Experimental group
Treatment:
Drug: LEO 29102
LEO 29102 1.0 mg/g cream
Experimental group
Treatment:
Drug: LEO 29102
LEO 29102 2.5 mg/g cream
Experimental group
Treatment:
Drug: LEO 29102
LEO 29102 cream vehicle
Placebo Comparator group
Treatment:
Drug: LEO 29102
Elidel® cream (pimecrolimus) 10 mg/g
Active Comparator group
Treatment:
Drug: Elidel®

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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