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Clinical Trials/EUCTR2014-002194-10-DE
EUCTR2014-002194-10-DE
Active, not recruiting
Not Applicable

An intra-individual randomized controlled study to evaluate the efficacy and tolerance of the product RV4421A BS0042 in association with a moderately potent topical corticosteroid in adults with Atopic Dermatitis

Pierre Fabre Dermo-Cosmétique0 sitesAugust 11, 2014
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ConditionsAtopic Dermatitis (arms, popliteal fossa)MedDRA version: 17.1Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 100000004858Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
DrugsLOCAPRED, 0.1% cream

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Atopic Dermatitis (arms, popliteal fossa)
Sponsor
Pierre Fabre Dermo-Cosmétique
Status
Active, not recruiting
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 11, 2014
End Date
TBD
Last Updated
10 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Pierre Fabre Dermo-Cosmétique

Eligibility Criteria

Inclusion Criteria

  • •Criteria related to the population:
  • •Patient male or female
  • •Patient aged between 18 and 65 years included
  • •Patient with phototype I, II, III or IV according to Fitzpatrick classification
  • •Patient having signed his/her written informed consent for his/her participation in the study
  • •Patient affiliated to a social security system or health insurance, or is a beneficiary
  • •For women of childbearing potential :
  • •ohaving been using an effective method of contraception (chirurgical or hormonal birth control or intrauterine device only) for at least 2 months before inclusion in the study,
  • •oaccepting to go on using it during the whole duration of the study and up to 5 days after the last product application, in order to avoid pregnancy while being exposed to the study products
  • •onegative urine pregnancy test

Exclusion Criteria

  • •Criteria related to the population:
  • •Patient unable to understand the information given (for linguistic or psychiatric reasons) and to give his/her consent in writing to participate
  • •Patient unable to understand the study procedures (for linguistic or psychiatric reasons) and to report required information in writing in his/her diary
  • •Patient who has forfeited his/her freedom by administrative or legal award or under guardianship
  • •Patient who is currently participating or who has participated in another clinical study within 1 month prior to inclusion visit
  • •Patient who, in the judgement of the investigator, is not likely to be compliant during the study
  • •For women: patient pregnant or breastfeeding
  • •Criteria related to the disease
  • •Skin disease on the study arms or legs other than AD liable to interfere with the assessment
  • •Primary bacterial, viral, fungal or parasitic infections on the application areas

Outcomes

Primary Outcomes

Not specified

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