Investigation of the Efficacy of 2.5% and 5% Cis-urocanic Acid in Patients With Moderate or Severe Atopic Dermatitis

PHASE2CompletedINTERVENTIONAL
Enrollment

159

Participants

Timeline

Start Date

March 31, 2011

Primary Completion Date

June 30, 2012

Study Completion Date

June 30, 2012

Conditions
Atopic Dermatitis
Interventions
DRUG

Cis-UCA 2.5% emulsion cream

2.5% cis-UCA in emulsion cream base twice daily, amount of a fingertip per one hand (i.e. palm + thumb + fingers) area, applied topically as a thin layer on the affected skin area of approximate size of maximally three hand areas for up to 28 days (one fingertip per one hand area)

DRUG

Cis-UCA 5% emulsion cream

5% cis-UCA in emulsion cream base twice daily, amount of a fingertip per one hand (i.e. palm + thumb + fingers) area, applied topically as a thin layer on the affected skin area of approximate size of maximally three hand areas for up to 28 days (one fingertip per one hand area)

DRUG

Placebo for cis-UCA emulsion cream

The placebo for cis-UCA product (emulsion cream base) twice daily, amount of a fingertip per one hand area applied topically as a thin layer on the affected skin area on of approximate size of maximally three hand areas for up to 28 days (one fingertip per one hand area).

DRUG

Protopic® 0.1% ointment

0.1% Protopic® twice daily, amount of a fingertip per one hand area applied topically as a thin layer on the affected skin area of approximate size of maximally three hand areas for up to 28 days (one fingertip per one hand area).

Trial Locations (7)

00200

Helsinki University Central Hospital, Skin and Allergy Hospital, Helsinki

Unknown

Mehiläinen Medical Center Kuopio, Kuopio

Lohja Hospital, Clinic of Dermatology and Allergology, Lohja

Mehiläinen Medical Center Turku, Turku

Pulssi Medical Center, Turku

Turku University Hospital, Department of Dermatology and Venereal Diseases, Turku

FI-33520

FinnMedi Oy, Tampere

Sponsors

Lead Sponsor

All Listed Sponsors
lead

BioCis Pharma Ltd

INDUSTRY