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Tolerance and Efficacy of Formulation 609580 20 Versus Formulation 609209 in Children With Atopic Dermatitis

NCT00931411 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2011-09-20

Study results available
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Summary

Atopic dermatitis is one of the most frequent skin diseases. The disease is often worst during winter months when the skin is drier. Mild to moderate cases of atopic dermatitis are often controlled by a moisturizer alone. The use of moisturizers has been shown to have beneficial effects on atopic dermatitis. It can break the dry skin cycle by hydrating the upper layer of the skin which may prevent the recurrence of the disease and can reduce the use of cream or ointment medications such as corticosteroids. Formulation 609580 20 was developed to keep the moisturizing efficacy of formulation 609209 but to improve its tolerance and cosmetic acceptability (easier to apply, nicer texture, etc.). The new formulation contains the same quantity of shea butter and glycerin but in a different excipient (inactive substance) than the commercial product. In addition, vitamin B3 was added to see if it could help in reducing itching.

The purpose of this study is to determine the safety and efficacy of two study products in children with atopic dermatitis. One of the study products (formulation 609580 20) is not commercially available (outside of clinical trials such as this one). The other study product (formulation 609209) has been approved in Canada and is currently available commercially under the trade name Lipikar Baume.

For this study the child will be randomly assigned to one of the following two groups:

* Group 1: 50 children will receive formulation 609209, the commercial formula for 42 days and will receive formulation 609580 20, the new formula, for 14 days.
* Group 2: 50 children will receive formulation 609580 20, the new formula, for 42 days and will receive formulation 609209, the commercial formula, for 14 days.

Conditions

Interventions

OTHER

Formulation 609580 20

Moisturizer, applied topically to whole body, twice a day, morning and evening, after bathing.

OTHER

Formulation 609209 (Lipikar Baume)

Moisturizer, applied topically to whole body, twice a day, morning and evening, after bathing.

Sponsors & Collaborators

  • Innovaderm Research Inc.

    collaborator OTHER

  • Cosmetique Active International

    lead INDUSTRY

Principal Investigators

  • Robert Bissonnette, MD · Innovaderm Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
3 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2009-06-30
Completion
2009-07-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00931411 on ClinicalTrials.gov