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Completed

NCT Number: NCT03252730

In-Use Test With a Cosmetic Product

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.

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Key information

Conditions

Dermatitis, Atopic Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SIT Skin Investigation and Technology Hamburg GmbH

Hamburg, 20354, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

WO 4260 Cosmetic Product for Topical Use

Other

Application on the hair scalp at least once a day over four weeks

Primary outcomes

  1. 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

Secondary outcomes

  1. Skin Hydration of the Scalp

    Time frame: before product treatment; after 2 and 4 weeks of treatment

    The measurement is performed using the DermaLab® device with the moisture pin (Cortex Technology)

  2. Performance of the Test Product

    Time frame: after 4 weeks of treatment

    Subjective assessment of product performance in a questionnaire-based interview

  3. Tolerance of the Test Product on the Scalp

    Time frame: after 2 weeks of treatment

    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.

Sponsors and collaborators

Lead sponsor

Dr. August Wolff GmbH & Co. KG Arzneimittel

Industry

Collaborators

  • SIT Skin Investigation and Technology Hamburg GmbH

Registry information

Official study title

In-Use Test With a Cosmetic Product (WO 4260) for Topical Use on the Scalp

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Aug 17, 2017
Registry last updated
Aug 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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