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Effect of Moisturising Creams on Skin Moisture in Atopic Dermatitis

Primary Purpose

Dermatitis, Atopic

Status

Completed

Phase

Phase 4

Locations

Finland

Study Type

Interventional

Intervention

Aqualan L, Aqualan Plus, Aqualan L + glycerol ad 20%

About this trial

This is an interventional treatment trial for Dermatitis, Atopic focused on measuring Dermatitis, Atopic, Moisturising cream, Skin

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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 Criteria:

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).

Sites / Locations

Orion Pharma R&D

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Moisturising cream

Arm Description

Outcomes

Primary Outcome Measures

Skin hydratation and transepidermal water loss.

Secondary Outcome Measures

Full Information

NCT ID

NCT00846235

First Posted

February 13, 2009

Last Updated

October 7, 2009

Sponsor

Orion Corporation, Orion Pharma

1. Study Identification

Unique Protocol Identification Number

NCT00846235

Brief Title

Effect of Moisturising Creams on Skin Moisture in Atopic Dermatitis

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2009

Overall Recruitment Status

Completed

Study Start Date

December 2008 (undefined)

Primary Completion Date

March 2009 (Actual)

Study Completion Date

May 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Orion Corporation, Orion Pharma

4. Oversight

Data Monitoring Committee

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dermatitis, Atopic

Keywords

Dermatitis, Atopic, Moisturising cream, Skin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Moisturising cream

Arm Type

Experimental

Intervention Type

Other

Intervention Name(s)

Aqualan L, Aqualan Plus, Aqualan L + glycerol ad 20%

Intervention Description

moisturising cream twice daily three weeks

Primary Outcome Measure Information:

Title

Skin hydratation and transepidermal water loss.

Time Frame

3 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pirjo Nykänen, PhD

Organizational Affiliation

Orion Pharma, R&D, Translational Sciences, Finland

Official's Role

Study Director

Facility Information:

Facility Name

Orion Pharma R&D

City

Espoo

ZIP/Postal Code

02101

Country

Finland

12. IPD Sharing Statement

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Effect of Moisturising Creams on Skin Moisture in Atopic Dermatitis

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