Safety, Tolerability and Pharmacokinetics of LEO 29102 Cream in Atopic Dermatitis.

LEO Pharma

Status and phase

Terminated

Phase 1

Conditions

Atopic Dermatitis

Treatments

Drug: LEO 29102 Cream Vehicle

Drug: LEO 29102

Study type

Interventional

Funder types

Industry

Identifiers

NCT01447758

LEO 29102-C26

Details and patient eligibility

About

The purpose of this Phase Ib study is to investigate the safety, tolerability and pharmacokinetics of LEO 29102 2,5 mg/g cream when treating atopic dermatitis (AD) lesions from 10 up to 100% of the body surface area (BSA) twice daily (BID) for 7 days (Cohorts I, II, III) and from 10% up to 50% of BSA (bid) for 6 weeks (Cohort IV). This trial will be performed in four cohorts. Cohort I, II and III includes patients with a larger BSA that increases from one cohort to the next. After each cohort (Cohort I, II)a blinded evaluation of the safety and tolerability data will assess whether a stepwise increase in the percentage of "to be treated BSA" is justified. Cohort IV will start dosing after finalisation of Cohort II and after submission of data from Cohort I and II to the national authority and IEC for review.

Enrollment

58 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

Clinical diagnosis of AD defined according to Hanifin and Rajka.
Investigator Global Assessment scored as mild (2) to severe (4) AD.
At screening, AD lesions amenable for treatment involving 10% to < 25% (Cohort I), 25% to < 50% (Cohort II), 50% to 100% (Cohort III) and 10% to < 50% (Cohort IV) of the total BSA.
On Day -1, AD lesions amenable for treatment involving 10% to < 28% (Cohort I), 25% to < 55% (Cohort II), 50% to 100% (Cohort III) and 10% to < 55% (Cohort IV) of the total BSA.
Adult male or female subjects, aged 18 to 65 years, inclusive.