Atopic Dermatitis (arms, popliteal fossa) MedDRA version: 17.1 Level: LLT Classification code 10003639 Term: Atopic dermatitis System Organ Class: 100000004858
Conditions
Interventions
Trade Name: LOCAPRED, 0.1% cream
Pharmaceutical Form: Cream
INN or Proposed INN: DESONIDE
Concentration unit: % (W/W) percent weight/weight
Concentration type: equal
Concentration number: 0.1-
Sponsors
Pierre Fabre Dermo-Cosmétique
Eligibility
Sex/Gender
All
Inclusion 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 : 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 4
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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).;Secondary Objective: • 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 ;Primary 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). ;Timepoint(s) of evaluation of this end point: Day 3 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary 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 maintenan | — |
Countries
Germany
Outcome results
None listed