In-Use Test of a Cosmetic Product in Subjects With Chronically Itchy Scalp

In-Use Test of a Shampoo (WO 5101) in Subjects With Pruritus of the Scalp

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03630107

Enrollment

Registered

2018-08-14

Start date

2018-02-15

Completion date

2018-03-15

Last updated

2023-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pruritus of the Scalp

Keywords

itchy scalp, chronic pruritus

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.

Interventions

OTHERWO 5101 Shampoo for Scalp and Hair

Wash the hair at least three times a week for a period of four weeks

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Dermatological Tolerance of the Test Product on the Scalp	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	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

Measure	Time frame	Description
Cosmetic Features of the Test Product	baseline, four weeks	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
Reduction of Pruritus	baseline, four weeks	Change from Baseline Reduction of Pruritus at four weeks by the means of a questionnaire

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026