Dermatitis, AtopicNCT03252730
In-Use Test With a Cosmetic Product
A study testing WO 4260 Cosmetic Product for Topical Use in people with Dermatitis, Atopic, 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 tolerance of the product WO 4260 by a dermatologist. Additional objectives of this clinical in-use study are to evaluate the cosmetic features and acceptance of the product by means of a questionnaire in an interview situation and by skin hydration measurements on the scalp. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dermatitis, Atopic
- What is being tested?
- WO 4260 Cosmetic Product for Topical Use
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteGermany
- Study dates
- 30 Jan 2017to 27 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age: ≥ 18 years
- sex: approx. 50% male and approx. 50% female
- users of hair tonic for dry scalp
- dry, itchy scalp prone to atopic eczema / atopic dermatitis
Who cannot join
- any deviation from the above-mentioned criteria
- users of sour hair rinse
- subjects who wash their hair more than once a day
- other dermatological disorders (scars, moles) on the scalp
- 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
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- systemic medication with anti-inflammatory agents and antibiotics within 2 weeks prior to starting of the study
- systemic medication with retinoids, antihistamines and/or immunomodulators (e.g. cortisone, corticosterone, chemotherapeutic agents) within 4 weeks prior to starting of the study
- systemic illness of the subject at the beginning of the study
- 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 4260) for Topical Use on the Scalp
The aim of the study is to evaluate the tolerance of the product WO 4260 by a dermatologist. Additional objectives of this clinical in-use study are to evaluate the cosmetic features and acceptance of the product by means of a questionnaire in an interview situation and by skin hydration measurements on the scalp.
- Conditions
- Dermatitis, Atopic
- Being tested
- WO 4260 Cosmetic Product for Topical Use
- Keywords
- Dry scalp, Itchy scalp
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WO 4260 Cosmetic Product for Topical UseOther
Application on the hair scalp at least once a day over four weeks
| Study group | Role | What they receive |
|---|---|---|
| WO 4260 Cosmetic Product for Topical Use | Experimental | WO 4260 is used to treat dry and itchy scalp Receives: Other: WO 4260 Cosmetic Product for Topical Use |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerance of the Test Product on the Scalp
Change from Baseline Tolerance on the Scalp at 4 weeks
Measured: after 4 weeks of treatment
Secondary outcomes (3)
Skin Hydration of the Scalp
The measurement is performed using the DermaLab® device with the moisture pin (Cortex Technology)
Measured: before product treatment; after 2 and 4 weeks of treatment
Performance of the Test Product
Subjective assessment of product performance in a questionnaire-based interview
Measured: after 4 weeks of treatment
Tolerance of the Test Product on the Scalp
Dermatological assessment of the Scalp concerning the Tolerance of the Test Product regarding erythema, edema dryness etc. Each item is scored 0=absent to 4=extreme.
Measured: after 2 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2017
- Study start30 Jan 2017
- Primary completion27 Feb 2017
- Study completion27 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermatitis, AtopicStudies 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
- 34 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
- Mona Mazinani, MD, Study director, SIT Skin Investigation and Technology Hamburg GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03252730
- Sponsor's protocol ID
- LPT-15/2016
- Status last verified
- Aug 2017
- First submitted
- 18 Jul 2017
- Last updated
- 22 Aug 2017
- 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 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In-Use Test With a Cosmetic Product (WO 4260) for Topical Use on the Scalp
- ClinicalTrials.gov ID
- NCT03252730
- Acronym / sponsor ID
- LPT-15/2016
- Conditions
- Dermatitis, Atopic
- Keywords
- Dry scalp, Itchy scalp
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Dr. August Wolff GmbH & Co. KG ArzneimittelIndustry (pharma, biotech, devices)
- Collaborators
- SIT Skin Investigation and Technology Hamburg GmbH
- Study start
- 30 Jan 2017 (actual)
- Primary completion
- 27 Feb 2017 (actual)
- Study completion
- 27 Feb 2017 (actual)
- First posted
- 17 Aug 2017 (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 tolerance of the product WO 4260 by a dermatologist. Additional objectives of this clinical in-use study are to evaluate the cosmetic features and acceptance of the product by means of a questionnaire in an interview situation and by skin hydration measurements on the scalp.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| WO 4260 Cosmetic Product for Topical Use | Experimental | Other: WO 4260 Cosmetic Product for Topical UseWO 4260 is used to treat dry and itchy scalp |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age: ≥ 18 years
- sex: approx. 50% male and approx. 50% female
- users of hair tonic for dry scalp
- dry, itchy scalp prone to atopic eczema / atopic dermatitis
Key exclusion criteria (10 listed)
- any deviation from the above-mentioned criteria
- users of sour hair rinse
- subjects who wash their hair more than once a day
- other dermatological disorders (scars, moles) on the scalp
- known incompatibilities to cosmetics and ingredients of cosmetic test products (please see INCI)
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 4260 Cosmetic Product for Topical UseApplication on the hair scalp at least once a day over four weeks | Other | WO 4260 Cosmetic Product for Topical Use |
Primary outcome
Tolerance of the Test Product on the Scalp
Time frame: after 4 weeks of treatment
Change from Baseline Tolerance on the Scalp at 4 weeks
3 secondary outcomes
Skin Hydration of the Scalp
Time frame: before product treatment; after 2 and 4 weeks of treatment
Performance of the Test Product
Time frame: after 4 weeks of treatment
Tolerance of the Test Product on the Scalp
Time frame: after 2 weeks of treatment
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 22 Aug 2017.
- Individual participant dataSharing planned: No
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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.
Mona Mazinani, MD study director
SIT Skin Investigation and Technology Hamburg GmbH
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 4260 Cosmetic Product for Topical Use in people with Dermatitis, Atopic, 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 4 inclusion and 10 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 22 Aug 2017. 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?
Tolerance of the Test Product on the Scalp (time frame: after 4 weeks of treatment). 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 22 Aug 2017.