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    Summary
    EudraCT Number:2014-002194-10
    Sponsor's Protocol Code Number:RV4421A2013147
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-08-11
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2014-002194-10
    A.3Full title of the trial
    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
    Intraindividuelle, randomisierte, kontrollierte Studie zur Evaluierung der Wirksamkeit und Verträglichkeit des Produkts RV4421A BS0042 in Kombination mit einem mittelstarken topischen Kortikosteroid bei Erwachsenen mit atopischer Dermatitis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to evaluate the efficacy and tolerance of a new restorative cream in association with a corticosteroid in adults with Atopic Dermatitis
    Studie zur Untersuchung der Wirksamkeit und Verträglichkeit einer neuen stärkenden Creme in Kombination mit einem Kortisonpräparat bei Erwachsenen mit Neurodermitis
    A.4.1Sponsor's protocol code numberRV4421A2013147
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorPierre Fabre Dermo-Cosmétique
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportPierre Fabre Dermo-Cosmétique
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationproDERM GmbH
    B.5.2Functional name of contact pointnot applicable
    B.5.3 Address:
    B.5.3.1Street AddressKiebitzweg 2
    B.5.3.2Town/ citySchenefeld
    B.5.3.3Post code22869
    B.5.3.4CountryGermany
    B.5.6E-mailAHougardy@proDERM.de
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name LOCAPRED, 0.1% cream
    D.2.1.1.2Name of the Marketing Authorisation holderPierre Fabre Dermatologie
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Cream
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDESONIDE
    D.3.9.4EV Substance CodeSUB07005MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.1
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Atopic Dermatitis (arms, popliteal fossa)
    E.1.1.1Medical condition in easily understood language
    Atopic Dermatitis (arms, popliteal fossa)
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level LLT
    E.1.2Classification code 10003639
    E.1.2Term Atopic dermatitis
    E.1.2System Organ Class 100000004858
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective will be to evaluate the benefit of the association of the product RV4421A BS0042 with a moderately potent topical corticosteroid compared with the moderately potent topical corticosteroid alone, in improvement of Atopic Dermatitis in adults, measured by the reduction of L-SCORAD at Day 3 (D3).
    E.2.2Secondary objectives of the trial
    • To evaluate the benefit of the association of the product RV4421A BS0042 with a moderately potent topical corticosteroid compared with the moderately potent topical corticosteroid alone in:
    o improvement of clinical and functional signs of Atopic Dermatitis
    o improvement of the skin instrumental parameters of Atopic Dermatitis
    • To evaluate the effect of a 2-week maintenance period of product RV4421A BS0042 twice daily application in:
    o improvement of clinical and functional signs of Atopic Dermatitis
    o improvement of the skin instrumental parameters of Atopic Dermatitis
    o time to relapse defined as a need of a treatment therapy and/or skin care product application
    • To assess the tolerance of the product RV4421A BS0042 alone, and in association with a moderately potent topical corticosteroid, under dermatological control
    • To evaluate the patients global satisfaction as regards to the use of the tested product RV4421A BS0042
    • To obtain illustrative photographs
    E.2.3Trial contains a sub-study No
    E.3Principal 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 :
    o having 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,
    o accepting 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
    o negative urine pregnancy test

    Criteria related to the disease:
    • Patient with a diagnosis of Atopic Dermatitis for at least one year
    • Patient with moderate to severe Atopic Dermatitis lesions symmetrical in terms of severity on both arms or on both popliteal fossa, whose scores index severity are as follows:
    o L-IGA = 3 or 4 (moderate or severe) assessed on a scale ranged from 0 to 5
    o L-SCORAD ≥ 6 assessed on a 18-point scale with:
     xerosis score ≥ 2 (moderate) on a scale ranged from 0 to 3
    o no difference by more than 1 score point between each component of the L-SCORAD of both arms or of both popliteal fossa
    o no more than 3 points of difference in the total L-SCORAD
    • Patient with Atopic Dermatitis lesions symmetrical in terms of extent on both arms or on both popliteal fossa: target lesions with a similar size on both arms or on both popliteal fossa, according to the judgement of the investigator
    E.4Principal 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
    • Ulcerated lesions on the application areas
    • History of disease considered by the investigator hazardous for the patient or incompatible with the study
    • On-going allergen reintroduction
    • On-going reintroduction diet within the framework of avoidance regimen (food allergy(ies))
    • Reintroduction diet
    • History of hypersensitivity or intolerance to any component of the test product and/or associated product’ ingredients

    Criteria related to treatments and products
    • Phototherapy for less than 4 weeks prior to inclusion or required during the study
    • Systemic immunosuppressive treatment within 4 weeks before the inclusion or required during the study
    • Systemic corticosteroids within 2 weeks before the inclusion or required during the study
    • Systemic antihistaminic established or modified within 2 weeks before the inclusion
    • Systemic antibiotics within 1 week before the inclusion or required during the study
    • Topical immunomodulators (TIMs), non-steroidal anti-inflammatory, corticosteroids, antihistaminics, antibiotics or antiseptics treatments applied on study arm(s) or leg(s) within 5 days before the inclusion or required during the study
    • Skin care product (including moisturizer) applied on study arm(s) or popliteal fossa within 2 days before the inclusion visit
    • Water or any cleansing product, applied on study arm(s) or popliteal fossa 4 hours before the inclusion visit

    E.5 End points
    E.5.1Primary end point(s)
    The primary criterion is the L-SCORAD index assessed independently on both study arms or on both popliteal fossa by the investigator on a scale ranged from 0 to 18, at Visit 2 (D3).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 3
    E.5.2Secondary end point(s)
    • The L-SCORAD index will be calculated by the investigator independently on both study arms or popliteal fossa on a scale ranged from 0 to 18, at visits V1, V3, V4 and V5
    • Each of the six objective signs of the SCORAD will be rated from 0 (absent) to 3 (severe) independently on both study arms or popliteal fossa by the investigator, at all visits.
    • The L-IGA (local investigator global assessment) score will be assessed by the investigator independently on both study arms or popliteal fossa on a 6-point scale ranged from 0 (clear) to 5 (very severe disease), at all visits.
    • The pruritus intensity will be evaluated by the patient independently on both study arms or popliteal fossa on a visual analog scale from 0 to 10, at each time and in case of lesions worsening during the 2nd period.
    • The L-PGA (local patients global assessment) will be evaluated by the patient independently on both study arms or popliteal fossa on a 5-point scale, at each time and in case of lesions worsening during the 2nd period in comparison to Atopic Dermatitis intensity on study arms or popliteal fossa at baseline
    • Each of the six objective signs of the PO-SCORAD (patient oriented SCORAD) will be rated from 0 (absent) to 3, independently on both study arms or popliteal fossa by the patient, at each time and in case of lesions worsening during the 2nd period.
    • The L-PO-SCORAD (local patient oriented SCORAD) index will be calculated by the patient independently on both study arms or popliteal fossa on a scale ranged from 0 to 18, at each time and in case of lesions worsening during the 2nd period.
    • TEWL (transepidermal water loss) on a target lesion of each study arm or popliteal fossa will be measured by Aquaflux at each visit
    • The time to Atopic Dermatitis relapse will be evaluated during the maintenance period (2 weeks), during which the associated product will not be applied anymore.
    • The percentage of flares occurred at the end of the maintenance period (D24) will be evaluated for each treatment arm (arm or leg with RV4421A BS0042 and arm or leg with no product application), two weeks after the end of associated product applications.
    • Patient’s global satisfaction as regards to the use of the test product RV4421A BS0042 will be assessed by the patient at the end of the study (at V4 or within 2 days before V5 or at V5) through a specific questionnaire.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 17 and 24
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Test product will be investigated in association with a topical corticosteroid compared to TCS alone
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of the trial is defined as the last visit of the last subject
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state54
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    At the end of the study the investigator will advise the subjects on further treatment of their Atopic Dermatitis. All strong skin reactions occurring during the trial, as well as all adverse events, however, will be further tended to by the investigator, either until the condition has cleared or until a stable condition has been achieved.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-11-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-11-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-07-09
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