In-Use Test With a Cosmetic Product to Treat Pruritus

Pruritus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03477058
• Other study ID #: LPC-17/2016
• Status: Completed
• Phase: N/A
• Start date: January 23, 2017
• Est. completion date: February 6, 2017

Study information

• Verified date: December 2023
• Source: Dr. August Wolff GmbH & Co. KG Arzneimittel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: February 6, 2017
• Est. primary completion date: February 6, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Pruritus

Intervention

Other:
• WO 3308 cosmetic product for topical use
Application on the entire body at least once a day over two weeks

Locations

Country	Name	City	State
Germany	SIT Skin Investigation and Technology Hamburg GmbH	Hamburg

Sponsors (2)

Lead Sponsor	Collaborator
Dr. August Wolff GmbH & Co. KG Arzneimittel	SIT Skin Investigation and Technology Hamburg GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cosmetic Features of the Test Product	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	baseline, two weeks
Primary	Reduction of Pruritus	Change from baseline reduction of pruritus at two weeks by the means of an interview-based questionnaire	baseline, two weeks
Secondary	Tolerance of the Test Product on the skin	Change from baseline at two weeks by the means of a dermatological and subjective assessment of skin tolerance on arms and legs	baseline, two weeks