In-Use Test With a Cosmetic Product

NCT03252730 | Completed

• 1 other identifier: LPT-15/2016
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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 the product by means of a questionnaire in an interview situation and by skin hydration measurements on the scalp.

Conditions

Dermatitis, Atopic

Keywords

Dry scalp; Itchy scalp

Outcome Measures

Primary Outcomes (1)

• Tolerance of the Test Product on the Scalp

  Change from Baseline Tolerance on the Scalp at 4 weeks

  after 4 weeks of treatment

Secondary Outcomes (3)

• Skin Hydration of the Scalp

  before product treatment; after 2 and 4 weeks of treatment

• Performance of the Test Product

  after 4 weeks of treatment

• Tolerance of the Test Product on the Scalp

  after 2 weeks of treatment

Study Arms (1)

WO 4260 Cosmetic Product for Topical Use

EXPERIMENTAL

WO 4260 is used to treat dry and itchy scalp

Other: WO 4260 Cosmetic Product for Topical Use

Interventions

WO 4260 Cosmetic Product for Topical Use OTHER

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

WO 4260 Cosmetic Product for Topical Use

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. August Wolff GmbH & Co. KG Arzneimittel: lead
• SIT Skin Investigation and Technology Hamburg GmbH: collaborator

Study Sites (1)

SIT Skin Investigation and Technology Hamburg GmbH

Hamburg, 20354, Germany

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

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

Study Officials

• Mona Mazinani, MD

  SIT Skin Investigation and Technology Hamburg GmbH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2017
• First Posted: August 17, 2017
• Study Start: January 30, 2017
• Primary Completion: February 27, 2017
• Study Completion: February 27, 2017
• Last Updated: August 22, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)