Dermatitis, Atopic
Conditions
Keywords
Dry scalp, Itchy scalp
Brief summary
The aim of the study is to evaluate the tolerance of the product WO 4260 by a dermatologist. Additional objectives of this clinical in-use study are to evaluate the cosmetic features and acceptance of the product by means of a questionnaire in an interview situation and by skin hydration measurements on the scalp.
Interventions
OTHERWO 4260 Cosmetic Product for Topical Use
Application on the hair scalp at least once a day over four weeks
Sponsors
SIT Skin Investigation and Technology Hamburg GmbH
Dr. August Wolff GmbH & Co. KG Arzneimittel
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* age: ≥ 18 years * sex: approx. 50% male and approx. 50% female * users of hair tonic for dry scalp * dry, itchy scalp prone to atopic eczema / atopic dermatitis
Exclusion criteria
* any deviation from the above-mentioned criteria * users of sour hair rinse * subjects who wash their hair more than once a day * other dermatological disorders (scars, moles) on the scalp * known incompatibilities to cosmetics and ingredients of cosmetic test products (please see INCI) * topical medication in the test area within 1 month prior to study start * systemic medication with anti-inflammatory agents and antibiotics within 2 weeks prior to starting of the study * systemic medication with retinoids, antihistamines and/or immunomodulators (e.g. cortisone, corticosterone, chemotherapeutic agents) within 4 weeks prior to starting of the study * systemic illness of the subject at the beginning of the study * pregnancy and period of breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tolerance of the Test Product on the Scalp | after 4 weeks of treatment | Change from Baseline Tolerance on the Scalp at 4 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Skin Hydration of the Scalp | before product treatment; after 2 and 4 weeks of treatment | The measurement is performed using the DermaLab® device with the moisture pin (Cortex Technology) |
| Performance of the Test Product | after 4 weeks of treatment | Subjective assessment of product performance in a questionnaire-based interview |
| Tolerance of the Test Product on the Scalp | after 2 weeks of treatment | Dermatological assessment of the Scalp concerning the Tolerance of the Test Product regarding erythema, edema dryness etc. Each item is scored 0=absent to 4=extreme. |
Countries
Germany
Outcome results
None listed