CLINICAL TRIAL OF CD5789 CREAM IN HEALTHY JAPANESE MALE SUBJECTS
Research type
Research Study
Full title
Safety Clinical Trial of CD5789 Cream 50µg/g and CD5789 Cream 100µg/g by Open Test, Patch Test and Photo Patch Test in Healthy Japanese Male Subjects
IRAS ID
136803
Contact name
Lorch Ulrike
Contact email
Sponsor organisation
GALDERMA R&D, SNC
Eudract number
2012-004635-23
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
N/A
Research summary
We are conducting a clinical research study with a medicinal cream coded as CD5789 which is being developed for skin diseases such as acne vulgaris, commonly known as acne. Acne is one of the most common skin diseases, affecting almost 80 percent of the population at some time, mostly between the ages of 11 and 30 years. In this study we will assess the local tolerability and photosensitivity (sensitivity to light) potential of CD5789 cream compared with CD5789 vehicle, and purified water in Japanese adult healthy male volunteers. This study will provide the sponsors with important safety information necessary for marketing CD5789 in various countries including Japan in future.
The study drugs will be applied to 5 application sites each on 4 skin areas on the back and we will perform assessments at different times after the drug application so we can compare the different treatments within the same volunteer. Volunteers will visit our clinical unit for screening and once enrolled, have a residential period over 5 or 6 days (4 or 5 nights). Volunteers will be involved in the study for up to 27 days including the interval time for us to judge their eligibility for the study. The main procedures will include standard laboratory safety tests (blood and urine samples), vital signs (blood pressure and pulse), general physical examinations, pharmacokinetic blood sample, open and closed patch tests with the study drugs on the back skin, UVA irradiation on the application site and monitoring of adverse events (i.e. side effects). Application sites on the back of volunteers will be photographed.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
13/SC/0405
Date of REC Opinion
30 Aug 2013
REC opinion
Further Information Favourable Opinion