Safety, Tolerability, Pharmacokinetics and Efficacy of WOL071-007 in Atopic Dermatitis Patients

PHASE1CompletedINTERVENTIONAL
Enrollment

58

Participants

Timeline

Start Date

March 31, 2014

Primary Completion Date

July 31, 2015

Study Completion Date

July 31, 2015

Conditions
Dermatitis, Atopic
Interventions
DRUG

0.1% WOL071-007

Application of approximately 2 mg cream/cm² skin to a defined surface area. SAD part: Single application to ≤ 100 cm² of non-lesional or lesional skin; MAD part: Multiple application (6 Days) to 2000 cm² of lesional and non-lesional skin.

DRUG

0.3% WOL071-007

Application of approximately 2 mg cream/cm² skin to a defined surface area. SAD part: Single application to ≤ 100 cm² of non-lesional or lesional skin; MAD part: Multiple application (6 Days) to 2000 cm² of lesional and non-lesional skin.

DRUG

1.0% WOL071-007

Application of approximately 2 mg cream/cm² skin to a defined surface area. SAD part: Single application to ≤ 100 cm² of non-lesional or lesional skin; MAD part: Multiple application (6 Days) to 2000 cm² of lesional and non-lesional skin.

DRUG

Placebo of WOL071-007

Application of approximately 2 mg cream/cm² skin to a defined surface area. SAD part: Single application to ≤ 100 cm² of non-lesional or lesional skin; MAD part: Multiple application (6 Days) to 2000 cm² of lesional and non-lesional skin.

Trial Locations (1)

14050

PAREXEL International GmbH Early Phase, Berlin

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Parexel

INDUSTRY

lead

Dr. August Wolff GmbH & Co. KG Arzneimittel

INDUSTRY