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In-Use Test With a Cosmetic Product to Treat Pruritus

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03477058
Enrollment
55
Registered
2018-03-26
Start date
2017-01-23
Completion date
2017-02-06
Last updated
2023-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pruritus

Keywords

chronic pruritus, acute pruritus

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.

Interventions

OTHERWO 3308 cosmetic product for topical use

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

Sponsors

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

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Cosmetic Features of the Test Productbaseline, two weeksChange 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
Reduction of Pruritusbaseline, two weeksChange from baseline reduction of pruritus at two weeks by the means of an interview-based questionnaire

Secondary

MeasureTime frameDescription
Tolerance of the Test Product on the skinbaseline, two weeksChange from baseline at two weeks by the means of a dermatological and subjective assessment of skin tolerance on arms and legs

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026