Effect of Moisturising Creams on Skin Moisture in Atopic Dermatitis

Dermatitis, Atopic Clinical Trial

Official title:

Clinical Evaluation of the Effect of Moisturising Cream on Skin Moisture in Atopic Dermatitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00846235
• Other study ID #: 2934004
• Status: Completed
• Phase: Phase 4
• First received: February 13, 2009
• Last updated: October 7, 2009
• Start date: December 2008
• Est. completion date: May 2009

Study information

• Verified date: October 2009
• Source: Orion Corporation, Orion Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The aim of this study is evaluate the effect of three moisturising creams on Stratum corneum (SC) hydratation and barrier function.

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 containing glycerol have been reported to be beneficial for AD lesions. The optimal glycerol content in moisturising creams is not known. The secondary objective is the comparison of change in the SC water content and in the TEWL from the skin surface from the baseline to the end of study between different moisturizing creams containing different amount of glycerol.

Change in the SC water content and in the TEWL can be demonstrated with noninvasive instrumental measurement. The treated skin will be followed up instrumentally, and one measurement area will serve as an untreated control. The primary evaluation is the comparison of change in the SC water content and in the TEWL on the skin surface from the baseline to the end of study between the 4 treatments.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

1. Written informed consent (IC) obtained.

2. 18-55 years of age, Caucasian, Finnish speaking, male or female subjects.

3. Weight at least 50 kg.

4. Body mass index (BMI) 18-30 kg/m2.

5. Clinical assessment for the diagnosis of mild or moderate atopic dermatitis

Exclusion Criteria:

1. Any clinically relevant medical condition judged by the investigator.

2. Any known allergy to ingredients of the test treatments.

3. Any systemic immunosuppressive or cortisone medication.

4. UV-Light therapy and sunlight exposure within 30 days prior to the start of the study and during study.

5. 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.

6. Anticipated difficulty related to stopping of caffeine intake during study centre visits.

7. 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.

8. Recent or current drug abuse or suspected abuse or positive result in screening of drug abuse.

9. Recent or current alcohol abuse (more than 16 units/week for women and more than 21 units/week for men) or suspected abuse.

10. Participation in another clinical study within 30 days prior to the start of the present study.

11. Predictable poor compliance or inability to communicate well with the investigator.

12. Inability to participate in all treatment periods.

13. Pregnant or lactating females.

14. 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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Other:
• Aqualan L, Aqualan Plus, Aqualan L + glycerol ad 20%
moisturising cream twice daily three weeks

Locations

Country	Name	City	State
Finland	Orion Pharma R&D	Espoo

Sponsors (1)

Lead Sponsor	Collaborator
Orion Corporation, Orion Pharma

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skin hydratation and transepidermal water loss.		3 weeks	No