Effect of Moisturising Creams on Skin Moisture in Atopic Dermatitis

NCT00846235 | Completed Phase 4

• 1 other identifier: 2934004
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dermatitis, Atopic

Keywords

Dermatitis; Atopic; Moisturising cream; Skin

Outcome Measures

Primary Outcomes (1)

• Skin hydratation and transepidermal water loss.

  3 weeks

Study Arms (1)

Moisturising cream

EXPERIMENTAL

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

Interventions

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

moisturising cream twice daily three weeks

Moisturising cream

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Written informed consent (IC) obtained.
• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Orion Corporation, Orion Pharma: lead

Study Sites (1)

Orion Pharma R&D

Espoo, 02101, Finland

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Dermatitis

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Pirjo Nykänen, PhD

  Orion Pharma, R&D, Translational Sciences, Finland

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 13, 2009
• First Posted: February 18, 2009
• Study Start: December 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: May 1, 2009
• Last Updated: October 8, 2009

Record last verified: 2009-10

Locations

FI (1)