PruritusNCT03477058
In-Use Test With a Cosmetic Product to Treat Pruritus
A study testing WO 3308 cosmetic product for topical use in people with Pruritus, run by Dr. August Wolff GmbH & Co. KG Arzneimittel at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Pruritus
- What is being tested?
- WO 3308 cosmetic product for topical use
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteGermany
- Study dates
- 23 Jan 2017to 6 Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
SIT Skin Investigation and Technology Hamburg GmbH
Hamburg, 20354
About this study
Official title: In-Use Test With a Cosmetic Product (WO 3308) for Topical Use to Treat Acute or Chronic 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.
- Conditions
- Pruritus
- Being tested
- WO 3308 cosmetic product for topical use
- Keywords
- chronic pruritus, acute pruritus
- Medical subject headings
- Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WO 3308 cosmetic product for topical useOther
Application on the entire body at least once a day over two weeks
| Study group | Role | What they receive |
|---|---|---|
| WO 3308 cosmetic product for topical use | Experimental | WO 3308 is used to treat acute or chronic pruritus Receives: Other: WO 3308 cosmetic product for topical use |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline, two weeks
Reduction of Pruritus
Change from baseline reduction of pruritus at two weeks by the means of an interview-based questionnaire
Measured: baseline, two weeks
Secondary outcomes (1)
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
Measured: baseline, two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2018
- Study start23 Jan 2017
- Primary completion6 Feb 2017
- Study completion6 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PruritusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. August Wolff GmbH & Co. KG Arzneimittel
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- SIT Skin Investigation and Technology Hamburg GmbH
- Responsible party
- Sponsor
- Investigators
- Alexandra Gust, MD, Study director, Dermatologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03477058
- Sponsor's protocol ID
- LPC-17/2016
- Status last verified
- Dec 2023
- First submitted
- 15 Mar 2018
- Last updated
- 19 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In-Use Test With a Cosmetic Product (WO 3308) for Topical Use to Treat Acute or Chronic Pruritus
- ClinicalTrials.gov ID
- NCT03477058
- Acronym / sponsor ID
- LPC-17/2016
- Conditions
- Pruritus
- Keywords
- chronic pruritus, acute pruritus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Dr. August Wolff GmbH & Co. KG ArzneimittelIndustry (pharma, biotech, devices)
- Collaborators
- SIT Skin Investigation and Technology Hamburg GmbH
- Study start
- 23 Jan 2017 (actual)
- Primary completion
- 6 Feb 2017 (actual)
- Study completion
- 6 Feb 2017 (actual)
- First posted
- 26 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| WO 3308 cosmetic product for topical use | Experimental | Other: WO 3308 cosmetic product for topical useWO 3308 is used to treat acute or chronic pruritus |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WO 3308 cosmetic product for topical useApplication on the entire body at least once a day over two weeks | Other | WO 3308 cosmetic product for topical use |
Primary outcome
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
1 secondary outcome
Tolerance of the Test Product on the skin
Time frame: baseline, two weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2023.
- Individual participant dataSharing planned: No
Related trials for Pruritus
Recruiting
Investigation of the Effects of Sleep Deprivation on Itch and Pain Sensitivity
Histamine, Cowhage
Active, not recruiting
Identification of the Mechanism of Non-histaminergic Itch Inducing Epigenetic Changes
Itch
Recruiting
Investigate the Relationship Between Catastrophizing and the Perception of Itch Intensity in Healthy Individuals
Histamine, Cowhage
RecruitingPhase 3
Roflumilast Cream 0.3% for Moderate to Severe Atopic Dermatitis
Atopic Dermatitis, Atopic Dermatitis (AD)
Recruiting
Topographical Distribution of Itch and Pain Receptors
Pain, Itch
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandra Gust, MD study director
Dermatologist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WO 3308 cosmetic product for topical use in people with Pruritus, run by Dr. August Wolff GmbH & Co. KG Arzneimittel at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cosmetic Features of the Test Product (time frame: baseline, two weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2023.