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Completed

NCT Number: NCT03477058

In-Use Test With a Cosmetic Product to Treat Pruritus

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.

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Key information

Conditions

Pruritus Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin Manifestations Skin and Connective Tissue Diseases

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: No

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

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

Treatment and study plan

WO 3308 cosmetic product for topical use

Other

Application on the entire body at least once a day over two weeks

Primary outcomes

  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 outcomes

  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

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 With a Cosmetic Product (WO 3308) for Topical Use to Treat Acute or Chronic Pruritus

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Mar 26, 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.

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