Status:

COMPLETED

In-Use Test With a Cosmetic Product

Lead Sponsor:

Dr. August Wolff GmbH & Co. KG Arzneimittel

Collaborating Sponsors:

SIT Skin Investigation and Technology Hamburg GmbH

Conditions:

Dermatitis, Atopic

Eligibility:

All Genders

18+ years

Phase:

NA

Brief 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...

Eligibility Criteria

Inclusion

  • 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

Exclusion

  • 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
  • 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

Key Trial Info

Start Date :

January 30 2017

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

February 27 2017

Estimated Enrollment :

34 Patients enrolled

Trial Details

Trial ID

NCT03252730

Start Date

January 30 2017

End Date

February 27 2017

Last Update

August 22 2017

Active Locations (1)

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SIT Skin Investigation and Technology Hamburg GmbH

Hamburg, Germany, 20354