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

Not Applicable

Completed

• Conditions: Pruritus of the Scalp
• Interventions: Other: WO 5101 Shampoo for Scalp and Hair

• Registration Number: NCT03630107
• Lead Sponsor: Dr. August Wolff GmbH & Co. KG Arzneimittel

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-15
• Primary Completion: 2018-03-15
• Study Completion: 2018-03-15
• Study First Submitted: 2018-08-06
• Study First Submitted QC: 2018-08-13
• Study First Posted: 2018-08-14
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-18
• Last Update Posted: 2023-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
WO 5101 Shampoo for Scalp and Hair	WO 5101 Shampoo for Scalp and Hair	WO 5101 is used in subjects with chronically itchy scalp

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

SIT Skin Investigation and Technology Hamburg GmbH; 🇩🇪 Hamburg, Germany