Effect of Moisturising Creams on Skin Moisture in Atopic Dermatitis

October 7, 2009 updated by: Orion Corporation, Orion Pharma

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Espoo, Finland, 02101
        • Orion Pharma R&D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Moisturising cream
Other: Aqualan L, Aqualan Plus, Aqualan L + glycerol ad 20%
moisturising cream twice daily three weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Skin hydratation and transepidermal water loss.
Time Frame: 3 weeks
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Orion Corporation, Orion Pharma

Investigators

  • Study Director: Pirjo Nykänen, PhD, Orion Pharma, R&D, Translational Sciences, Finland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

February 13, 2009

First Submitted That Met QC Criteria

February 16, 2009

First Posted (Estimate)

February 18, 2009

Study Record Updates

Last Update Posted (Estimate)

October 8, 2009

Last Update Submitted That Met QC Criteria

October 7, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2934004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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