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inola F® on Skin Physiology of patients with atopic dermatitis

Phase 3
Conditions
Atopic dermatitis with mild to moderate sevirty (SCORAD below than 12)).
Atopic dermatitis
Registration Number
IRCT2015062017994N1
Lead Sponsor
Sina Tejart Pishgam® company
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
25
Inclusion Criteria

Inclusion Criteria:
Case of Mild to moderate atopic dermatitis
Aged (>2) years old
At least 2 lesions on arms or legs with identical local SCORAD
Written Informed Consent
Having a negative pregnancy test
Willingness to actively participate in the study and to come to the scheduled visits respectively willingness of parents/legal guardians to actively participate in the study and to come to the scheduled visits
Willingness to discontinue the use of any conventional skin care products (e.g. creams, lotions, sunscreens) at the treatment areas of Linola F throughout the course of the study

Exclusion Criteria

Pregnancy or lactation
Severe Atopic eczema (local SCORAD >12)
Drug addicts, alcoholics
One of the following serious illnesses, if not medicated: cardiovascular diseases, asthma, hypertension
Active skin disease at test area (except atopic dermatitis)
Moles, tattoos, scars, hairs, dark pigmentation etc. at the test area that could influence the investigation
Documented allergies to cosmetic products
History of HIV
History of Hepatitis C
History of Hepatitis B
Being involved in any other research project /clinical trial

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Trans Epidermal Water Loss(TEWL). Timepoint: Visit 0, 2 week after Visit 0, 4 week after Visit 0. Method of measurement: MPA.;Corneometer. Timepoint: Visit 0, 2 week after Visit 0, 4 week after Visit 0. Method of measurement: MPA.
Secondary Outcome Measures
NameTimeMethod
SCORAD Measure. Timepoint: Visit 0, 2 week after Visit 0, 4 week after Visit 0. Method of measurement: SCORAD.;Burning, Iching, Temperature, Sebum, PH ,Mexameter. Timepoint: v. Method of measurement: MPA, calculating measures.;Thickness , Density. Timepoint: Visit 0, 2 week after Visit 0, 4 week after Visit 0. Method of measurement: Ultrasonography.;Satisfaction with the solution treatment. Timepoint: 2 week after Visit 0, 4 week after Visit 0. Method of measurement: questionnaire.
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