Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| SIT Skin Investigation and Technology Hamburg GmbH | OTHER |
Not provided
Not provided
Not provided
Not provided
The aim of the study is to evaluate the tolerance of the Shampoo (WO 5101) on the scalp by a dermatologist and by the subjects themselves after four weeks of regular product use.
Additional objective of this clinical in-use study was to evaluate the cosmetic features and the acceptance of the product by means of a questionnaire at the end of the 4-week treatment period.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WO 5101 Shampoo for Scalp and Hair | Experimental | WO 5101 is used in subjects with chronically itchy scalp |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WO 5101 Shampoo for Scalp and Hair | Other | Wash the hair at least three times a week for a period of four weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dermatological Tolerance of the Test Product on the Scalp | Change from Baseline at four weeks by the means of a dermatological assessment of scalp
all Parameters (a-j) were assessed by 6-tiered rating scale with 0.5 intervals (0=absent; 0.5=very slight, 1/1.5= slight; 2/2.5=moderate; 3/3.5=severe and 4=extreme) | baseline, four weeks |
| Subjective Tolerance of the Test Product on the Scalp | Change from baseline at four weeks by means of a self-assessment questionnaire (with 13 questions regarding cosmetic features of the product as well as satisfaction with cosmetic performance). | baseline, four weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Cosmetic Features of the Test Product | Change from Baseline for the Cosmetic Features (scalp feeling after application, fragrance, hair styling, combability, lightness of the hair) of the Test Product by the means of a questionnaire | baseline, four weeks |
| Reduction of Pruritus |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kerstin Söhl, MD | Dermatologist | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SIT Skin Investigation and Technology Hamburg GmbH | Hamburg | 20354 | Germany |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Change from Baseline Reduction of Pruritus at four weeks by the means of a questionnaire |
| baseline, four weeks |