Effect of Moisturising Creams on Skin Moisture in Atopic Dermatitis

This study has been completed.
Sponsor:
Information provided by:
Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier:
NCT00846235
First received: February 13, 2009
Last updated: October 7, 2009
Last verified: October 2009
  Purpose

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


Condition Intervention Phase
Dermatitis, Atopic
Other: Aqualan L, Aqualan Plus, Aqualan L + glycerol ad 20%
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of the Effect of Moisturising Cream on Skin Moisture in Atopic Dermatitis

Further study details as provided by Orion Corporation, Orion Pharma:

Primary Outcome Measures:
  • Skin hydratation and transepidermal water loss. [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: December 2008
Study Completion Date: May 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Moisturising cream Other: Aqualan L, Aqualan Plus, Aqualan L + glycerol ad 20%
moisturising cream twice daily three weeks

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00846235

Locations
Finland
Orion Pharma R&D
Espoo, Finland, 02101
Sponsors and Collaborators
Orion Corporation, Orion Pharma
Investigators
Study Director: Pirjo Nykänen, PhD Orion Pharma, R&D, Translational Sciences, Finland
  More Information

No publications provided

Responsible Party: Kimmo Ingman MD PhD, Orion Corporation, Orion Pharma, R&D
ClinicalTrials.gov Identifier: NCT00846235     History of Changes
Other Study ID Numbers: 2934004
Study First Received: February 13, 2009
Last Updated: October 7, 2009
Health Authority: Finland: Ethics Committee

Keywords provided by Orion Corporation, Orion Pharma:
Dermatitis
Atopic
Moisturising cream
Skin

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on September 18, 2014