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Completed

NCT Number: NCT03630107

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

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.

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Key information

Conditions

Pruritus of the Scalp

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SIT Skin Investigation and Technology Hamburg GmbH

Hamburg, 20354, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

WO 5101 Shampoo for Scalp and Hair

Other

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

Primary outcomes

  1. Dermatological Tolerance of the Test Product on the Scalp

    Time frame: baseline, four weeks

    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)

  2. Subjective Tolerance of the Test Product on the Scalp

    Time frame: 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 outcomes

  1. Cosmetic Features of the Test Product

    Time frame: 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

  2. Reduction of Pruritus

    Time frame: baseline, four weeks

    Change from Baseline Reduction of Pruritus at four weeks by the means of a questionnaire

Sponsors and collaborators

Lead sponsor

Dr. August Wolff GmbH & Co. KG Arzneimittel

Industry

Collaborators

  • SIT Skin Investigation and Technology Hamburg GmbH

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 14, 2018
Registry last updated
Dec 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.