In-Use Test With a Cosmetic Product to Treat Pruritus
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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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pruritus | Other: WO 3308 cosmetic product for topical use | Not Applicable |
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 |

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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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

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
Germany | |
SIT Skin Investigation and Technology Hamburg GmbH | |
Hamburg, Germany, 20354 |
Study Director: | Alexandra Gust, MD | Dermatologist |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
chronic pruritus acute pruritus |
Pruritus Skin Diseases Skin Manifestations |