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

NCT00931411 | Terminated Results

• 2 other identifiers: LRP07019CCER 08-09-009
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 5

Brief 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

Atopic Dermatitis

Keywords

Atopic Dermatitis; Vitamin B3

Outcome Measures

Primary Outcomes (1)

• Mean Percent Change in SCORAD (Scoring Atopic Dermatitis) From Day 0

  The efficacy of formulation 609580 20 to provide relief to children with atopic dermatitis compared to formulation 609209 as measured by the changes in SCORAD at Day 7 and Day 42. It measures intensity of erythema/darkening, edema/papulation, oozing/crust, excoriation, lichenfinication/prurigo and dryness on a scale from 0-3 for a total of 18 points. This score is multiplided by 3.5 and added to 1/5 of the affected percent body surface area. The final score is added to the score from a 10-point pruritus visual analog scale (VAS) and a 10-point loss of sleep VAS. Best score is 0, worst is 103.

  7 , 42 days

Secondary Outcomes (8)

• Change in Mean Global Efficacy (by Investigator).

  7, 42 Days

• Change in Mean Global Efficacy (by Parent)

  7, 42 days

• Change in Mean Quality of Life

  0, 42 days

• Change in Mean Cosmetic Acceptability Before Crossover

  0, 42 days

• Change in Mean Cosmetic Acceptability After Crossover

  14 days (Day 42 to Day 56 of the study)

Study Arms (2)

Formulation 609580 20 then 609209

EXPERIMENTAL

Formulation 609580 20 cream is applied topically to the entire body twice a day, morning and evening, after bathing for 42 days. This is followed by the same application of formulation 609209 for 2 weeks. Dosage is at the discretion of the parent applying the cream to the child.

Other: Formulation 609580 20; Other: Formulation 609209 (Lipikar Baume)

Formulation 609209 then 609580 20

ACTIVE COMPARATOR

Formulation 609209 cream is applied topically to entire body, twice a day, morning and evening, after bathing for 42 days. This is followed by the same application of formulation 609580 20 for 2 weeks. Dosage is at the discretion of the parent applying the cream to the child.

Other: Formulation 609580 20; Other: Formulation 609209 (Lipikar Baume)

Interventions

Formulation 609580 20 OTHER

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

Formulation 609209 then 609580 20; Formulation 609580 20 then 609209

Formulation 609209 (Lipikar Baume) OTHER

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

Also known as: Lipikar Baume

Formulation 609209 then 609580 20; Formulation 609580 20 then 609209

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• years of age
• Suffering from a mild to moderate atopic dermatitis that is amenable to treatment with moisturizer only
• SCORAD (scoring atopic dermatitis) of 10-30 at screening and Day 0
• Diagnosis of atopic dermatitis must meet Hanifin's criteria (at least 3 basic features and at least 3 minor features; please refer to appendix D)
• Atopic dermatitis has been, in the opinion of the investigator, stable for the past 28 days
• Subject with parents able to apply the study product twice a day (each morning and evening) for a 56 days period
• Subject with parents agreeing not to change their child's lifestyle during the study period (including their usual body hygiene product (soap), the number of baths and showers per day, the laundry detergent and fabric softener used to wash the child's clothes)
• Subject with parents agreeing that their child uses only the test product as body emollient on the whole body during the study period
• Subject with parents available to completely follow the study with their child
• Subject with parents able and willing to sign the informed consent form and to comply with the study regulations of this protocol

You may not qualify if:

• Subject has another dermatological condition that could interfere with clinical evaluation including infected atopic dermatitis lesions
• Subject has a previous history of allergy to cosmetic products or any ingredients of the tested formulations
• Subject has received any systemic treatment, including PUVA (psoralen ultraviolet A) therapy for atopic dermatitis within 28 days prior to screening
• Subject has received any topical immunomodulators for atopic dermatitis (such as pimecrolimus or tacrolimus) within 14 days of Day 0
• Subject has received phototherapy within 14 days of Day 0
• Subject intends to expose him/herself to the sun during the trial
• Subject has known allergy to any component of tested products
• Subject has used any experimental treatment within 14 days of Day 0
• Subject has used any topical corticosteroid of class I-IV within 14 days of Day 0

Sponsors & Collaborators

• Cosmetique Active International: lead
• Innovaderm Research Inc.: collaborator

Study Sites (5)

The Guenther Dermatology Research Center

London, Ontario, Canada

Location

Lynderm Research

Markham, Ontario, Canada

Location

Innovaderm Research Inc

Laval, Quebec, Canada

Location

Innovaderm Research Inc

Montreal, Quebec, Canada

Location

Centre de recherche dermatologique du Québec Métropolitain

Québec, Quebec, Canada

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Annie Levesque
• Organization: Innovaderm Research

alevesque@innovaderm.ca

514-521-4285

Study Officials

• Robert Bissonnette, MD

  Innovaderm Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President and Dermatologist

Study Record Dates

• First Submitted: June 29, 2009
• First Posted: July 2, 2009
• Study Start: January 1, 2009
• Primary Completion: June 1, 2009
• Study Completion: July 1, 2009
• Last Updated: September 20, 2011
• Results First Posted: February 3, 2011

Record last verified: 2011-09

Locations

CA (5)