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

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ClinicalTrials.gov Identifier: NCT03630107
Recruitment Status : Completed
First Posted : August 14, 2018
Last Update Posted : August 14, 2018
Sponsor:
Collaborator:
SIT Skin Investigation and Technology Hamburg GmbH
Information provided by (Responsible Party):
Dr. August Wolff GmbH & Co. KG Arzneimittel

Study Description
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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.


Condition or disease Intervention/treatment Phase
Pruritus of the Scalp Other: WO 5101 Shampoo for Scalp and Hair Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: In-Use Test of a Shampoo (WO 5101) in Subjects With Pruritus of the Scalp
Actual Study Start Date : February 15, 2018
Actual Primary Completion Date : March 15, 2018
Actual Study Completion Date : March 15, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cosmetics Itching

Arms and Interventions
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Arm Intervention/treatment
Experimental: WO 5101 Shampoo for Scalp and Hair
WO 5101 is used in subjects with chronically itchy scalp
 Other: WO 5101 Shampoo for Scalp and Hair
Wash the hair at least three times a week for a period of four weeks


Outcome Measures
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Primary Outcome Measures :
  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

    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)


  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03630107


Locations
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Germany
SIT Skin Investigation and Technology Hamburg GmbH
Hamburg, Germany, 20354
Sponsors and Collaborators
Dr. August Wolff GmbH & Co. KG Arzneimittel
SIT Skin Investigation and Technology Hamburg GmbH
Investigators
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Study Director: Kerstin Söhl, MD Dermatologist
More Information
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Responsible Party: Dr. August Wolff GmbH & Co. KG Arzneimittel
ClinicalTrials.gov Identifier: NCT03630107    
Other Study ID Numbers: LPS-05/2017
First Posted: August 14, 2018    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. August Wolff GmbH & Co. KG Arzneimittel:
itchy scalp
chronic pruritus
Additional relevant MeSH terms:
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Pruritus
Skin Diseases
Skin Manifestations