Atopic DermatitisNCT02589392

Cetaphil Restoraderm Effect on Young Children With Atopic Dermatitis

A study testing Cetaphil® Restoraderm® moisturizer + Cetaphil® Restoraderm® body wash and Cetaphil® Restoraderm® body wash in people with Atopic Dermatitis, run by Galderma R&D at 8 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 2 to 12 years
Conditions the study is for: Atopic Dermatitis
What is being tested?: Cetaphil® Restoraderm® moisturizer + Cetaphil® Restoraderm® body wash and Cetaphil® Restoraderm® body wash
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 120 participants
Where: 8 sitesin 2 countries
Study dates: 29 May 2015to 3 Feb 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 2 to 12 years
All sexes
No healthy volunteers
Child

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

8 sites in 2 countries.

Country

City, postcode or hospital

8 sites in 2 countries

China4 sites

Department of Dermatology /Beijing Children's Hospital
Beijing, XI Cheng, 100045
Hunan Children's Hospital
Hunan, Hunan, 410007
Department of Dermatology /Shenzhen Children's hospital
Shenzhen, Guangdong, 518026
XinHua Hospital
Yangpu, Shanghai Municipality, 200092

Other trials in China

Philippines4 sites

St. Luke's Medical Center
City of Taguig, Taguig City, 1634
Philippine General Hospital
Manila, Ermita, 1000
Asian Hospital and Medical Center
Manila, Muntinlupa City, 1780
Jose R. Reyes Memorial Medical Center
Manila, 1003

Other trials in Philippines

About this study

Official title: Effect of Cetaphil® Restoraderm® Moisturizer on Very Dry Skin in Children With a Controlled Atopic Dermatitis:a Randomised, Parallel Group Study

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.

Read the detailed description

Two groups randomized in a ratio of [1:1] for a 12-week period Five study evaluation were planned: at Baseline, week 2, Week 4, Week8 and Week12

Conditions: Atopic Dermatitis
Being tested: Cetaphil® Restoraderm® moisturizer + Cetaphil® Restoraderm® body wash, Cetaphil® Restoraderm® body wash
Medical subject headings: Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Cetaphil® Restoraderm® moisturizer + Cetaphil® Restoraderm® body washOther
Cetaphil® Restoraderm® body washOther

Study groups in NCT02589392
Study group	Role	What they receive
Moisturizer + Body wash	Experimental	Cetaphil® Restoraderm® moisturizer (2/day) + Cetaphil® Restoraderm® Skin body wash (1/day) Receives: Other: Cetaphil® Restoraderm® moisturizer + Cetaphil® Restoraderm® body wash
Body wash	Active comparator	Cetaphil® Restoraderm® body wash (1/day) Receives: Other: Cetaphil® Restoraderm® body wash

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 May 20153 Feb 2016

First posted28 Oct 2015 (estimated)
Study start29 May 2015
Primary completion3 Feb 2016
Study completion3 Feb 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Atopic DermatitisStudies of the same condition, open and under way.
More trials run by Galderma R&DThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02589392
Sponsor's protocol ID: RD.03.SPR.29110
Status last verified: Feb 2024
First submitted: 23 Oct 2015
Last updated: 26 Feb 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 29143926

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
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Evaluating the Safety and Tolerability of Baricitinib in Patients With Job Syndrome With Lupus-Like Disease and/or Atopic Dermatitis
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RecruitingObservational study
This Study is a Non-interventional Disease Registry of Adolescent and Adult Patients With Atopic Dermatitis Who Initiate or Switch Any Systemic Treatment
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RecruitingPhase 2
Cardamom and Topical Roseomonas in Atopic Dermatitis
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Not yet recruitingPhase 1
A Study of NOR-101 in Healthy Adults and Adults With Moderate-to-Severe Atopic Dermatitis
Atopic Dermatitis (AD)

All Atopic Dermatitis trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Cetaphil® Restoraderm® Moisturizer on Very Dry Skin in Children With a Controlled Atopic Dermatitis:a Randomised, Parallel Group Study
ClinicalTrials.gov ID: NCT02589392
Acronym / sponsor ID: RD.03.SPR.29110
Conditions: Atopic Dermatitis
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: Galderma R&DIndustry (pharma, biotech, devices)
Study start: 29 May 2015 (actual)
Primary completion: 3 Feb 2016 (actual)
Study completion: 3 Feb 2016 (actual)
First posted: 28 Oct 2015 (estimated)
Results: Posted 26 Feb 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Two groups randomized in a ratio of [1:1] for a 12-week period Five study evaluation were planned: at Baseline, week 2, Week 4, Week8 and Week12

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
Moisturizer + Body wash	Experimental	Other: Cetaphil® Restoraderm® moisturizer + Cetaphil® Restoraderm® body washCetaphil® Restoraderm® moisturizer (2/day) + Cetaphil® Restoraderm® Skin body wash (1/day)
Body wash	Active comparator	Other: Cetaphil® Restoraderm® body washCetaphil® Restoraderm® body wash (1/day)

Who may qualify

Ages: 2 to 12 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (2 listed)

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.

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Cetaphil® Restoraderm® moisturizer + Cetaphil® Restoraderm® body wash	Other	Moisturizer + Body wash
Cetaphil® Restoraderm® body wash	Other	Body wash

Primary outcome

Time to Relapse (Quantile 25%)
Time frame: The duration between Baseline and the first AD relapse occurred (up to 89 days)
Time to relapse corresponds to date of relapse - date of baseline. Quantile 25% replaced the median time to relapse that was not reached.

Results and safety

Results posted to the registry on 26 Feb 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Moisturizer + Body Wash	60	54
Body Wash	60	54

Primary outcome: Time to Relapse (Quantile 25%)

Time frame: The duration between Baseline and the first AD relapse occurred (up to 89 days). Number (95% Confidence Interval). Unit: Days

Measure	Moisturizer + Body Wash n = 60	Body Wash n = 60
Value	48 (11 to 86)	15 (8 to 27)

Population analysed: Analysis was performed on intent-to-treat efficacy (ITT) population that included all participants who were enrolled and randomized.

Adverse events

Time frame: 8 months. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Moisturizer + Body Wash	0 of 60 (0%)	14 of 60 (23.3%)	0 of 60
Body Wash	0 of 60 (0%)	17 of 60 (28.3%)	0 of 60

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29143926Ma 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.

Related trials for Atopic Dermatitis

RecruitingObservational study
Observational Analytical Validation Study of the Replior ScratchSense
Atopic Dermatitis, Other Pruritic Dermatological
RecruitingPhase 1
Evaluating the Safety and Tolerability of Baricitinib in Patients With Job Syndrome With Lupus-Like Disease and/or Atopic Dermatitis
Hyper IgE Syndrome From STAT3 Mutation, Job s Syndrome
RecruitingObservational study
This Study is a Non-interventional Disease Registry of Adolescent and Adult Patients With Atopic Dermatitis Who Initiate or Switch Any Systemic Treatment
Atopic Dermatitis
RecruitingPhase 2
Cardamom and Topical Roseomonas in Atopic Dermatitis
Atopic Dermatitis, Eczema
Not yet recruitingPhase 1
A Study of NOR-101 in Healthy Adults and Adults With Moderate-to-Severe Atopic Dermatitis
Atopic Dermatitis (AD)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

8 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in China, Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Relapse (Quantile 25%) (time frame: The duration between Baseline and the first AD relapse occurred (up to 89 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02589392, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2024.