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In-Use Test With a Cosmetic Product to Treat Pruritus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03477058
Recruitment Status : Completed
First Posted : March 26, 2018
Last Update Posted : August 13, 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 cosmetic features of the product WO 3308 by means of a questionnaire in an interview situation after two weeks of product treatment, giving special consideration to the cosmetic performance, efficacy and skin compatibility and with special focus on the reduction of pruritus. Additionally the tolerance will be evaluated by a dermatologist.

Condition or disease Intervention/treatment Phase
Pruritus Other: WO 3308 cosmetic product for topical use Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: In-Use Test With a Cosmetic Product (WO 3308) for Topical Use to Treat Acute or Chronic Pruritus
Actual Study Start Date : January 23, 2017
Actual Primary Completion Date : February 6, 2017
Actual Study Completion Date : February 6, 2017

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 3308 cosmetic product for topical use
WO 3308 is used to treat acute or chronic pruritus
 Other: WO 3308 cosmetic product for topical use
Application on the entire body at least once a day over two weeks


Outcome Measures
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Primary Outcome Measures :
  1. Cosmetic Features of the Test Product [ Time Frame: baseline, two weeks ]
    Change from baseline for the cosmetic features (spreadability, absorbtion, skin feeling after application, fragrance) of the test product by the means of an interview-based questionnaire

  2. Reduction of Pruritus [ Time Frame: baseline, two weeks ]
    Change from baseline reduction of pruritus at two weeks by the means of an interview-based questionnaire


Secondary Outcome Measures :
  1. Tolerance of the Test Product on the skin [ Time Frame: baseline, two weeks ]
    Change from baseline at two weeks by the means of a dermatological and subjective assessment of skin tolerance on arms and legs


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:   No
Criteria

Inclusion Criteria:

  • age: ≥ 18 years
  • sex: approx. 25% to 50% male and 50% to 75% female
  • with acute pruritus (lasts less than 6 weeks) or chronic pruritus (lasts longer than 6 weeks): max. 50% with acute pruritus and at least 50% with chronic pruritus

Exclusion Criteria:

  • any deviation from the above-mentioned criteria
  • 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 antibiotics within 2 weeks prior to starting of the study
  • change in the medication with anti-inflammatory agents within 2 weeks prior to starting the study
  • systemic medication with immunomodulators (immunsuppressive drugs in the course of a transplantation) and/or chemotherapeutic agents within 4 weeks prior to starting the study
  • neurodermatitis (atopic dermatitis)
  • pregnancy and period of breastfeeding
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): NCT03477058


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: Alexandra Gust, MD Dermatologist
More Information
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Responsible Party: Dr. August Wolff GmbH & Co. KG Arzneimittel
ClinicalTrials.gov Identifier: NCT03477058    
Other Study ID Numbers: LPC-17/2016
First Posted: March 26, 2018    Key Record Dates
Last Update Posted: August 13, 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:
chronic pruritus
acute pruritus
Additional relevant MeSH terms:
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Pruritus
Skin Diseases
Skin Manifestations