In-Use Test of a Shampoo (WO 5101) in Subjects With Pruritus of the Scalp
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 34
- Locations
- 2
- Primary Endpoint
- Dermatological Tolerance of the Test Product on the Scalp
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •age: ≥ 18 years
- •with chronically itchy scalp
- •normal to dry scalp or scalp prone to neurodermatitis
Exclusion Criteria
- •any deviation from the above-mentioned criteria
- •users of sour hair conditioner
- •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 two weeks prior to starting of the study
- •systemic medication with retinoids, antihistamines and/or immunomodulators (e.g. cortisone, corticosterone, chemotherapeutic agents) within four weeks prior to starting of the study
- •severe internistic disease that leads to pruritus
Outcomes
Primary Outcomes
Dermatological Tolerance of the Test Product on the Scalp
Time Frame: baseline, four weeks
Change from Baseline at four weeks by the means of a dermatological assessment of scalp 1. erythema 2. edema 3. dryness 4. scaliness 5. papules 6. pustules 7. fissures 8. pruritus 9. burning 10. Tension 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)
Subjective Tolerance of the Test Product on the Scalp
Time Frame: baseline, four weeks
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).
Secondary Outcomes
- Cosmetic Features of the Test Product(baseline, four weeks)
- Reduction of Pruritus(baseline, four weeks)