CompletedNCT03477058Updated Dec 19, 2023

In-Use Test With a Cosmetic Product to Treat Pruritus

An interventional study of WO 3308 cosmetic product for topical use in Pruritus, sponsored by Dr. August Wolff GmbH & Co. KG Arzneimittel. Completed at 1 site in Germany. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2023-12-19.

Sponsored by Dr. August Wolff GmbH & Co. KG Arzneimittel · Not applicable, Interventional, and Treatment

From the registry’s dates

Registered 1 year 1 month after the study started (first participant enrolled Jan 2017, registered Mar 2018).

Phase: Not applicable
Study type: Interventional
Enrollment: 55
Allocation: Not applicable
Ages: 18 Years to 99 Years
Sex: All

Study 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.

Conditions studied

Pruritus

Browse trials for

Pruritus 490

Keywords

chronic pruritus
acute pruritus

In context

Pruritus

490 studies on the registry are indexed under Pruritus; 93 are open to participants now.

This study's enrollment of 55 is close to the median of 60 across 422 interventional studies indexed under Pruritus.

Browse Pruritus studies →

Lead sponsor

Dr. August Wolff GmbH & Co. KG Arzneimittel is the lead sponsor of 18 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 99 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 55 participants (actual)

Study arms

Experimental
WO 3308 cosmetic product for topical use
WO 3308 is used to treat acute or chronic pruritus
Other: WO 3308 cosmetic product for topical use

Interventions

OtherWO 3308 cosmetic product for topical use
Application on the entire body at least once a day over two weeks

What researchers measure

Primary outcomes

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
Time frame: baseline, two weeks
Reduction of Pruritus
Change from baseline reduction of pruritus at two weeks by the means of an interview-based questionnaire
Time frame: baseline, two weeks

Secondary outcomes

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
Time frame: baseline, two weeks

Study locations

1 site

SIT Skin Investigation and Technology Hamburg GmbH
Hamburg, 20354, Germany

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2017 to primary completion in Feb 2017, 0 months.

Of 101 interventional studies with no phase under Pruritus, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 13. This study's 0 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered: Mar 15, 2018
First posted: Mar 26, 2018
StartActual: Jan 23, 2017
Primary completionActual: Feb 6, 2017
CompletionActual: Feb 6, 2017
Last update: Dec 19, 2023

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Dec 19, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03477058
Lead sponsor: Dr. August Wolff GmbH & Co. KG Arzneimittel
Collaborators: SIT Skin Investigation and Technology Hamburg GmbH
Responsible party: Sponsor
First posted: Mar 26, 2018
Start date: Jan 23, 2017
Primary completion: Feb 6, 2017
Completion: Feb 6, 2017
Last update: Dec 19, 2023

Study contacts

Alexandra Gust, MD

study director · Dermatologist

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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