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

NCT03630107 | Completed

• 1 other identifier: LPS-05/2017
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Pruritus of the Scalp

Keywords

itchy scalp; chronic pruritus

Outcome Measures

Primary Outcomes (2)

• Dermatological Tolerance of the Test Product on the Scalp

  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)

  baseline, four weeks

• 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 Outcomes (2)

• Cosmetic Features of the Test Product

  baseline, four weeks

• Reduction of Pruritus

  baseline, four weeks

Study Arms (1)

WO 5101 Shampoo for Scalp and Hair

EXPERIMENTAL

WO 5101 is used in subjects with chronically itchy scalp

Other: WO 5101 Shampoo for Scalp and Hair

Interventions

WO 5101 Shampoo for Scalp and Hair OTHER

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

WO 5101 Shampoo for Scalp and Hair

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age: ≥ 18 years
• with chronically itchy scalp
• normal to dry scalp or scalp prone to neurodermatitis

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. August Wolff GmbH & Co. KG Arzneimittel: lead
• SIT Skin Investigation and Technology Hamburg GmbH: collaborator

Study Sites (1)

SIT Skin Investigation and Technology Hamburg GmbH

Hamburg, 20354, Germany

Location

Study Officials

• Kerstin Söhl, MD

  Dermatologist

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2018
• First Posted: August 14, 2018
• Study Start: February 15, 2018
• Primary Completion: March 15, 2018
• Study Completion: March 15, 2018
• Last Updated: December 19, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)