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

Pruritus of the Scalp Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03630107
• Other study ID #: LPS-05/2017
• Status: Completed
• Phase: N/A
• Start date: February 15, 2018
• Est. completion date: March 15, 2018

Study information

• Verified date: December 2023
• Source: Dr. August Wolff GmbH & Co. KG Arzneimittel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: March 15, 2018
• Est. primary completion date: March 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Pruritus
• Pruritus of the Scalp

Intervention

Other:
• WO 5101 Shampoo for Scalp and Hair
Wash the hair at least three times a week for a period of four weeks

Locations

Country	Name	City	State
Germany	SIT Skin Investigation and Technology Hamburg GmbH	Hamburg

Sponsors (2)

Lead Sponsor	Collaborator
Dr. August Wolff GmbH & Co. KG Arzneimittel	SIT Skin Investigation and Technology Hamburg GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dermatological Tolerance of the Test Product on the Scalp	Change from Baseline at four weeks by the means of a dermatological assessment of scalp; erythema; edema; dryness; scaliness; papules; pustules; fissures; pruritus; burning; 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)	baseline, four weeks
Primary	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
Secondary	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
Secondary	Reduction of Pruritus	Change from Baseline Reduction of Pruritus at four weeks by the means of a questionnaire	baseline, four weeks