Status:
COMPLETED
Effect of Moisturising Creams on Skin Moisture in Atopic Dermatitis
Lead Sponsor:
Orion Corporation, Orion Pharma
Conditions:
Dermatitis, Atopic
Eligibility:
All Genders
18-55 years
Phase:
PHASE4
Brief Summary
The aim of this study is evaluate the effect of three moisturising creams on Stratum corneum (SC) hydratation and barrier function.
Detailed Description
In the present study, 24 subjects with AD will be treated for 3 weeks twice daily by using 3 different moisturising creams. Duration of the study is based on literature. Various moisturising creams co...
Eligibility Criteria
Inclusion
- Written informed consent (IC) obtained.
- 18-55 years of age, Caucasian, Finnish speaking, male or female subjects.
- Weight at least 50 kg.
- Body mass index (BMI) 18-30 kg/m2.
- Clinical assessment for the diagnosis of mild or moderate atopic dermatitis
Exclusion
- Any clinically relevant medical condition judged by the investigator.
- Any known allergy to ingredients of the test treatments.
- Any systemic immunosuppressive or cortisone medication.
- UV-Light therapy and sunlight exposure within 30 days prior to the start of the study and during study.
- Any abnormal physical finding which may interfere with the interpretation of test results or cause a health risk for the subject if he/she participates in the study.
- Anticipated difficulty related to stopping of caffeine intake during study centre visits.
- Current use of nicotine containing products more than 5 cigarettes (or equivalent)/day and inability to refrain from the use of nicotine containing products during the study.
- Recent or current drug abuse or suspected abuse or positive result in screening of drug abuse.
- Recent or current alcohol abuse (more than 16 units/week for women and more than 21 units/week for men) or suspected abuse.
- Participation in another clinical study within 30 days prior to the start of the present study.
- Predictable poor compliance or inability to communicate well with the investigator.
- Inability to participate in all treatment periods.
- Pregnant or lactating females.
- Females of childbearing potential if they are not using proper contraception (hormonal contraception, intrauterine device (IUD) or surgical sterilization, spermicidal foam in conjunction with condom on male partner) (Note: women of childbearing potential with no current sexual relationship can be included without contraception according to the judgement of the investigator).
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00846235
Start Date
December 1 2008
End Date
May 1 2009
Last Update
October 8 2009
Active Locations (1)
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1
Orion Pharma R&D
Espoo, Finland, 02101