ATOPIC DERMATITIS BIOTHERAPY
Conditions
Interventions
Group 1: Lipikar group (Lipikar Baume AP+ M plus syndet AP+) + Dupilumab or Cyclosporine treatment
Group 2: Non Lipikar group (non-Lipikar emollient plus cleanser) + Dupilumab or Cyclosporine treatmen
Sponsors
COSMETIQUE ACTIVE INTERNATIONAL
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Males or females aged =18 or = 60 years; SCORAD score = 40; VASpruritus =3; Hanifin's Criteria; No known allergy or intolerance to any component of the test preparations; Actively cooperating to participate in the study; Female subjects agreeing to use an adequate method of birth control if of child-bearing potential; Female subjects must show a negative urine pregnancy test at screening (V1); Agreeing to follow the instructions of the investigator and to attend the centre at the agreed time; Agreeing not to use any dermatological drug or cosmetic other than the testing products on the test area during the study; Signed informed consent form after the nature of the study has been fully explained.
Exclusion criteria
Exclusion criteria: Age outside the range 18 to 60 years; Pregnancy or lactation period; Hypersensitivity to any components of the study preparations; Use of any other dermatological drug or cosmetic preparation on the test area during the study; Any systemic or topical medication likely to interfere with the study purposes, particularly immunosuppressive or mmunomodulator therapy such as corticosteroids within three weeks prior to study enrolment; Any procedure possibly interfering with the immune system during the study; Any skin disease possibly interfering with the measured parameters; Any acute and/or chronic disease possibly interfering with the measured parameters; Participation in another clinical study/use of experimental drug(s) within the previous 30 days and/or during the study; Cigarette consumption higher than 10 per day; History or evidence of drug or alcohol abuse; Impaired cooperation or unwillingness to satisfactorily participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The efficacy of the treatment with Lipikar Baume AP+ M plus syndet AP+ compared to a non-Lipikar care regime to provide relief to subjects with atopic dermatitis as measured by the changes in VAS Pruritus Score at Day 28, Day 42, Day 56 and Day 70. The efficacy of the treatment with Lipikar Baume AP+ M plus syndet AP+ compared to a non-Lipikar care regime to provide relief to subjects with atopic dermatitis as measured by SCORAD at Day 28, Day 42, Day 56 and Day 70. The efficacy of the treatment with Lipikar Baume AP+ M plus syndet AP+ compared to a non-Lipikar care regime to provide relief to subjects with atopic dermatitis as measured by the change in the DLQI. | — |
Secondary
| Measure | Time frame |
|---|---|
| Tolerance grading by dermatologist & patients Questionnaires on efficacy / cosmeticity Photographic documentation of selected lesional site (same site as used for assessment of local SCORAD) Incidence of treatment emergent adverse events (TEAE). | — |
Countries
Germany
Contacts
Public ContactThomas LÜGER
Klinik für Hautkrankheiten Von-Esmarch
Outcome results
None listed