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

Dr. August Wolff

Status: Completed

Conditions: Pruritus of the Scalp

Treatments: Other: WO 5101 Shampoo for Scalp and Hair

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03630107

LPS-05/2017

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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34 participants in 1 patient group

WO 5101 Shampoo for Scalp and Hair

Experimental group

Description:

WO 5101 is used in subjects with chronically itchy scalp

Treatment:

Other: WO 5101 Shampoo for Scalp and Hair