Pruritus of the ScalpNCT03630107

In-Use Test of a Cosmetic Product in Subjects With Chronically Itchy Scalp

A study of Pruritus of the Scalp, run by Dr. August Wolff GmbH & Co. KG Arzneimittel at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The aim of the study is to evaluate the tolerance of the Shampoo (WO 5101) on the scalp by a dermatologist and by the subjects themselves after four weeks of regular product use. Read more about this study

Who is it for?: Ages 18 to 99 yearsHealthy volunteers can take part
Conditions the study is for: Pruritus of the Scalp
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 34 participants
Where: 1 siteGermany
Study dates: 15 Feb 2018to 15 Mar 2018
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
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

age: ≥ 18 years
with chronically itchy scalp
normal to dry scalp or scalp prone to neurodermatitis

Who cannot join

any deviation from the above-mentioned criteria
users of sour hair conditioner
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 two weeks prior to starting of the study
systemic medication with retinoids, antihistamines and/or immunomodulators (e.g. cortisone, corticosterone, chemotherapeutic agents) within four weeks prior to starting of the study
severe internistic disease that leads to pruritus

Trial locations and contacts

1 site in 1 country.

Germany1 site

SIT Skin Investigation and Technology Hamburg GmbH
Hamburg, 20354

Other trials in Germany

About this study

Official title: In-Use Test of a Shampoo (WO 5101) in Subjects With Pruritus of the Scalp

The aim of the study is to evaluate the tolerance of the Shampoo (WO 5101) on the scalp by a dermatologist and by the subjects themselves after four weeks of regular product use.

Additional objective of this clinical in-use study was to evaluate the cosmetic features and the acceptance of the product by means of a questionnaire at the end of the 4-week treatment period.

Conditions: Pruritus of the Scalp
Being tested: WO 5101 Shampoo for Scalp and Hair
Keywords: itchy scalp, chronic pruritus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

WO 5101 Shampoo for Scalp and HairOther
Wash the hair at least three times a week for a period of four weeks

Study groups in NCT03630107
Study group	Role	What they receive
WO 5101 Shampoo for Scalp and Hair	Experimental	WO 5101 is used in subjects with chronically itchy scalp Receives: Other: WO 5101 Shampoo for Scalp and Hair

What is being measured

The primary outcome is the main question the study is designed to answer.

Dermatological Tolerance of the Test Product on the Scalp
Change from Baseline at four weeks by the means of a dermatological assessment of scalp
1. erythema
2. edema
3. dryness
4. scaliness
5. papules
6. pustules
7. fissures
8. pruritus
9. burning
10. Tension all Parameters (a-j) were assessed by 6-tiered rating scale with 0.5 intervals (0=absent; 0.5=very slight, 1/1.5= slight; 2/2.5=moderate; 3/3.5=severe and 4=extreme)
Measured: baseline, four weeks
Subjective Tolerance of the Test Product on the Scalp
Change from baseline at four weeks by means of a self-assessment questionnaire (with 13 questions regarding cosmetic features of the product as well as satisfaction with cosmetic performance).
Measured: baseline, four weeks

Secondary outcomes (2)

Cosmetic Features of the Test Product
Change from Baseline for the Cosmetic Features (scalp feeling after application, fragrance, hair styling, combability, lightness of the hair) of the Test Product by the means of a questionnaire
Measured: baseline, four weeks
Reduction of Pruritus
Change from Baseline Reduction of Pruritus at four weeks by the means of a questionnaire
Measured: baseline, four weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Feb 201815 Mar 2018

First posted14 Aug 2018
Study start15 Feb 2018
Primary completion15 Mar 2018
Study completion15 Mar 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Pruritus of the ScalpStudies 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)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03630107
Sponsor's protocol ID: LPS-05/2017
Status last verified: Dec 2023
First submitted: 6 Aug 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 of a Shampoo (WO 5101) in Subjects With Pruritus of the Scalp
ClinicalTrials.gov ID: NCT03630107
Acronym / sponsor ID: LPS-05/2017
Conditions: Pruritus of the Scalp
Keywords: itchy scalp, chronic pruritus
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: 15 Feb 2018 (actual)
Primary completion: 15 Mar 2018 (actual)
Study completion: 15 Mar 2018 (actual)
First posted: 14 Aug 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 tolerance of the Shampoo (WO 5101) on the scalp by a dermatologist and by the subjects themselves after four weeks of regular product use.

Additional objective of this clinical in-use study was to evaluate the cosmetic features and the acceptance of the product by means of a questionnaire at the end of the 4-week treatment period.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
WO 5101 Shampoo for Scalp and Hair	Experimental	Other: WO 5101 Shampoo for Scalp and HairWO 5101 is used in subjects with chronically itchy scalp

Who may qualify

Ages: 18 to 99 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

age: ≥ 18 years
with chronically itchy scalp
normal to dry scalp or scalp prone to neurodermatitis

Key exclusion criteria (9 listed)

any deviation from the above-mentioned criteria
users of sour hair conditioner
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 5101 Shampoo for Scalp and HairWash the hair at least three times a week for a period of four weeks	Other	WO 5101 Shampoo for Scalp and Hair

Primary outcome

Dermatological Tolerance of the Test Product on the Scalp
Time frame: baseline, four weeks
Change from Baseline at four weeks by the means of a dermatological assessment of scalp 1. erythema 2. edema 3. dryness 4. scaliness 5. papules 6. pustules 7. fissures 8. pruritus 9. burning 10. Tension all Parameters (a-j) were assessed by 6-tiered rating scale with 0.5 intervals (0=absent; 0.5=very slight, 1/1.5= slight; 2/2.5=moderate; 3/3.5=severe and 4=extreme)
Subjective Tolerance of the Test Product on the Scalp
Time frame: baseline, four weeks
Change from baseline at four weeks by means of a self-assessment questionnaire (with 13 questions regarding cosmetic features of the product as well as satisfaction with cosmetic performance).

2 secondary outcomes

Cosmetic Features of the Test Product
Time frame: baseline, four weeks
Reduction of Pruritus
Time frame: baseline, four 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

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.

Kerstin Söhl, 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 of Pruritus of the Scalp, 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 9 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?

Dermatological Tolerance of the Test Product on the Scalp (time frame: baseline, four 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?

On the ClinicalTrials.gov record for NCT03630107.

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; AzTrials last refreshed its copy on 8 Nov 2026.