NCT02589392

Brief Summary

The purpose of this study is to evaluate the effect of Cetaphil® Restoraderm® skin restoring moisturizer in reducing the signs and symptoms of very dry atopic skin in young children. Subjects with atopic dermatitis (AD) in remission phase will be randomized to receive either Cetaphil® Restoraderm® skin restoring body wash only, or the same body wash in association with Cetaphil® Restoraderm® skin restoring moisturizer.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2015

Shorter than P25 for not_applicable

Geographic Reach
2 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 29, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 23, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 28, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 3, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 3, 2016

Completed
8.1 years until next milestone

Results Posted

Study results publicly available

February 26, 2024

Completed
Last Updated

February 26, 2024

Status Verified

February 1, 2024

Enrollment Period

8 months

First QC Date

October 23, 2015

Results QC Date

February 15, 2018

Last Update Submit

February 12, 2024

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

  • Time to Relapse (Quantile 25%)

    Time to relapse corresponds to date of relapse - date of baseline. Quantile 25% replaced the median time to relapse that was not reached.

    The duration between Baseline and the first AD relapse occurred (up to 89 days)

Study Arms (2)

Moisturizer + Body wash

EXPERIMENTAL

Cetaphil® Restoraderm® moisturizer (2/day) + Cetaphil® Restoraderm® Skin body wash (1/day)

Other: Cetaphil® Restoraderm® moisturizer + Cetaphil® Restoraderm® body wash

Body wash

ACTIVE COMPARATOR

Cetaphil® Restoraderm® body wash (1/day)

Other: Cetaphil® Restoraderm® body wash

Interventions

Cetaphil® Restoraderm® moisturizer + Cetaphil® Restoraderm® body washOTHER
Moisturizer + Body wash
Cetaphil® Restoraderm® body washOTHER
Body wash

Eligibility Criteria

Age2 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Male or female subject, aged 2 to 12 years inclusive
  • Controlled mild to moderate atopic dermatitis with a Investigator Global Assessment score at 0 or 1, within one week after successful treatment with topical corticosteroid.

You may not qualify if:

  • Subject presenting bacterial, viral, fungal or parasite skin infection
  • Subject with ulcerated lesions, acne or rosacea
  • Immunosuppression
  • Subject with a wash-out period from baseline for topical treatment less than 8 days for Calcineurin inhibitor
  • Subject with a wash-out period from baseline for topical treatment more than 8 days for corticosteroid
  • Subject with a wash-out period from baseline for systemic treatment less than 8 days for anti-histamines, less than 4 weeks for immunomodulators

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Department of Dermatology /Shenzhen Children's hospital

Shenzhen, Guangdong, 518026, China

Location

Hunan Children's Hospital

Hunan, Hunan, 410007, China

Location

XinHua Hospital

Yangpu, Shanghai Municipality, 200092, China

Location

Department of Dermatology /Beijing Children's Hospital

Beijing, XI Cheng, 100045, China

Location

Philippine General Hospital

Manila, Ermita, 1000, Philippines

Location

Asian Hospital and Medical Center

Manila, Muntinlupa City, 1780, Philippines

Location

St. Luke's Medical Center

City of Taguig, Taguig City, 1634, Philippines

Location

Jose R. Reyes Memorial Medical Center

Manila, 1003, Philippines

Location

Related Publications (1)

  • Ma L, Li P, Tang J, Guo Y, Shen C, Chang J, Kerrouche N. Prolonging Time to Flare in Pediatric Atopic Dermatitis: A Randomized, Investigator-Blinded, Controlled, Multicenter Clinical Study of a Ceramide-Containing Moisturizer. Adv Ther. 2017 Dec;34(12):2601-2611. doi: 10.1007/s12325-017-0640-6. Epub 2017 Nov 16.

    PMID: 29143926DERIVED

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Results Point of Contact

Title
Stéphanie Leclerc
Organization
Galderma
stephanie.leclerc@galderma.com
+33492386706

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2015

First Posted

October 28, 2015

Study Start

May 29, 2015

Primary Completion

February 3, 2016

Study Completion

February 3, 2016

Last Updated

February 26, 2024

Results First Posted

February 26, 2024

Record last verified: 2024-02

Locations

PH(4)CN(4)