AzTrials
AzTrials

Atopic DermatitisPhase 3NCT01467362

Efficacy Emollient on Xerosis in Children With Atopic Dermatitis

A Phase 3 study testing V0034CR01B, desonide 0.1% cream and Foaming gel in people with Atopic Dermatitis, run by Pierre Fabre Medicament at 25 sites in 5 countries.

Completed

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

Official record
Search all trials

Trial summary

Atopic dermatitis is a frequent, chronic inflammatory disease influenced by local, immunological, genetic and environmental factors. Important symptoms of atopic dermatitis are dry skin, intense pruritus and impaired epidermal barrier function. Read more about this study

Who is it for?
Ages 2 to 6 years
Conditions the study is for
Atopic Dermatitis
What is being tested?
V0034CR01B, desonide 0.1% cream and Foaming gel
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
251 participants
Where
25 sitesin 5 countries
Study dates
Nov 2011to May 2012
Phase
Phase 3
Are there results?
None posted in the registry

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 6 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Presenting with atopic dermatitis, dry skin, objective SCORAD < 15,
  • With xerosis on the body and a xerosis score > = 2 (SCORAD sub-score) on the anterior part of lower limbs,

Who cannot join

  • Acute phase of atopic dermatitis
  • Severe form of atopic dermatitis

Trial locations and contacts

25 sites in 5 countries.

25 sites in 5 countries

Poland9 sites

  • Poland

    Bialystok

  • Poland

    Inowrocław

  • Poland

    Lodz

  • Poland

    Oleśnica

  • Poland

    Płock

  • Poland

    Poznan

  • Poland

    Strzelce Opolskie

  • Poland

    Warsaw

  • Poland

    Żyrardów

Other trials in Poland

Romania8 sites

  • Romania

    Brasov

  • Romania

    Bucharest

  • Romania

    Constanța

  • Romania

    Craiova

  • Romania

    Iași

  • Romania

    Ploieşti

  • Romania

    Sibiu

  • Romania

    Târgu Mureş

Other trials in Romania

France5 sites

  • France

    Bordeaux

  • France

    Martigues

  • France

    Nantes

  • France

    Nice

  • France

    Poitiers

Other trials in France

Estonia2 sites

  • Estonia

    Tallinn

  • Estonia

    Tartu

Other trials in Estonia

Lithuania1 site

  • Lithuania

    Vilnius

Other trials in Lithuania

About this study

Official title: Efficacy of the V0034CR01B Emollient on Xerosis in Children With Atopic Dermatitis. Randomised, Vehicle-controlled, Parallel-groups, Double-blind Study With an Open Label Extension.

Atopic dermatitis is a frequent, chronic inflammatory disease influenced by local, immunological, genetic and environmental factors. Important symptoms of atopic dermatitis are dry skin, intense pruritus and impaired epidermal barrier function. Atopic dermatitis is associated with skin barrier dysfunction that facilitates an easier allergen penetration into the skin with an increased irritation and subsequent cutaneous inflammation. A lack of important stratum corneum intercellular lipids and an inadequate ratio between compounds enhance trans-epidermal water loss leading to xerosis. Skin hydration by emollient therapy usually twice daily improves dryness and subsequently pruritus during the treatment of atopic dermatitis and especially improves the barrier function. Emollients make part of basic therapy (grade 1) for treatment of atopic dermatitis (European Academy of Dermatology and Venereology Task Force 2009 Position Paper). Improvement of cutaneous barrier alteration, measured by skin hydration, is a key element for evaluation of emollient treatment efficacy.

The primary objective of this study is to demonstrate the efficacy of the tested product (V0034CR01B) cream on xerosis in children with atopic dermatitis compared to the excipient formula during 28 days.

Being tested
V0034CR01B, Vehicle cream, desonide 0.1% cream, Foaming gel
Keywords
xerosis, dry skin, dermatitis, pruritus, eczema, emollient, corticosteroid
Medical subject headings
Dermatitis, Atopic, Dermatitis, Pruritus, Eczema

What participants receive

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

  • V0034CR01BDrug

    Cream Out of flares: 1 application bid (morning and evening) During flares: 1 application once a day (in the morning) Maximum 91 days

  • Vehicle creamDrug

    Cream Out of flares: 1 application bid (morning and evening) During flares: 1 application once a day (in the morning) Maximum 28 days

  • desonide 0.1% creamDrug

    Also called Locapred

    cream, once a day (in the evening) during flares

  • Foaming gelOther

    Also called Pediatril

    for the washing and cleaning

Study groups in NCT01467362
Study groupRoleWhat they receive
V0034CR01BExperimentalNot described
Receives: Drug: V0034CR01B; Drug: desonide 0.1% cream; Other: Foaming gel
Vehicle creamPlacebo comparatorNot described
Receives: Drug: Vehicle cream; Drug: desonide 0.1% cream; Other: Foaming gel

What is being measured

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

  1. Xerosis score: mean evolution over the different time-points of double-blind period

    Measured: During 28 days (Day 1, Day 7, Day 14, Day 21 and Day 28)

Secondary outcomes (8)

  1. Hydration Index score : measurement of the skin hydration

    Measured: Day 1, Day 14, Day 28, Day 56 and Day 84

  2. Xerosis score evolution over the different time-ponts during open label period

    Measured: At Visit1 (Day 1) and at Day 56 and Day 84

  3. Xerosis Visual Analogue Scale (evaluation skin dryness)

    Measured: Day 1, Day 14, Day 28, Day 56 and Day 84

  4. Scoring for Atopic Dermatitis (SCORAD) : measurement of objective symptoms of Atopic Dermatitis.

    Measured: Day1, Day 28, Day 56 and Day 84.

  5. Overall assessment of treatment efficacy by the investigator

    Measured: Day 28 and Day 84

  6. Overall assessment of treatment efficacy and use by the parent(s)/guardian(s)

    Measured: at Day 28 and at Day 84

  7. Assessment of the local tolerability and the systemic safety (reported adverse events)

    Measured: Day 1, Day 7, Day 14, Day 21, Day 28, Day 56 and Day 84

  8. Topical corticosteroid assessment

    Measured: Day 7, Day 14, Day 21, Day 28, Day 56 and Day 84

Timeline

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

  1. First posted8 Nov 2011 (estimated)
  2. Study startNov 2011
  3. Primary completionMay 2012
  4. Study completionMay 2012

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
251 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01467362
Sponsor's protocol ID
V00034 CR 3 12 1B
Other IDs
2011-003295-37
Status last verified
Feb 2013
First submitted
24 Oct 2011
Last updated
21 Feb 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing V0034CR01B, desonide 0.1% cream and Foaming gel in people with Atopic Dermatitis, run by Pierre Fabre Medicament at 25 sites in 5 countries.

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 2 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 21 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in Poland, Romania, France, Estonia, Lithuania. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Xerosis score: mean evolution over the different time-points of double-blind period (time frame: During 28 days (Day 1, Day 7, Day 14, Day 21 and Day 28)). 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 NCT01467362.

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 21 Feb 2013.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in