In-Use Test With a Cosmetic Product to Treat Pruritus

NCT03477058 | Completed

• 1 other identifier: LPC-17/2016
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Pruritus

Keywords

chronic pruritus; acute pruritus

Outcome Measures

Primary Outcomes (2)

• 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

• Reduction of Pruritus

  Change from baseline reduction of pruritus at two weeks by the means of an interview-based questionnaire

  baseline, two weeks

Secondary Outcomes (1)

• Tolerance of the Test Product on the skin

  baseline, two weeks

Study Arms (1)

WO 3308 cosmetic product for topical use

EXPERIMENTAL

WO 3308 is used to treat acute or chronic pruritus

Other: WO 3308 cosmetic product for topical use

Interventions

WO 3308 cosmetic product for topical use OTHER

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

WO 3308 cosmetic product for topical use

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. August Wolff GmbH & Co. KG Arzneimittel: lead
• SIT Skin Investigation and Technology Hamburg GmbH: collaborator

Study Sites (1)

SIT Skin Investigation and Technology Hamburg GmbH

Hamburg, 20354, Germany

Location

MeSH Terms

Conditions

Pruritus

Condition Hierarchy (Ancestors)

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

Study Officials

• Alexandra Gust, MD

  Dermatologist

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2018
• First Posted: March 26, 2018
• Study Start: January 23, 2017
• Primary Completion: February 6, 2017
• Study Completion: February 6, 2017
• Last Updated: December 19, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)