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Impact of Exposure to Cosmetics on Sensitive Skin (SENSICOS)

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ClinicalTrials.gov Identifier: NCT03958968
Recruitment Status : Recruiting
First Posted : May 22, 2019
Last Update Posted : May 22, 2019
Sponsor:
Information provided by (Responsible Party):
BRENAUT Emilie, University Hospital, Brest

Tracking Information
First Submitted Date May 20, 2019
First Posted Date May 22, 2019
Last Update Posted Date May 22, 2019
Actual Study Start Date April 9, 2019
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 20, 2019)
Comparison of cosmetics use between subjects with and without sensitive skin [ Time Frame: during the inclusion visit ]
Ingredients contained in the cosmetics, type of products used and frequencies of use between a group of subjects with sensitive skin and a group without sensitive skin
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Impact of Exposure to Cosmetics on Sensitive Skin
Official Title Impact of Exposure to Cosmetics on Sensitive Skin
Brief Summary

The concept of sensitive or reactive skin was evoked in 1947 and developed in the 1970s and is now widely recognized. The international pruritus society has proposed an international consensus definition: sensitive skin is defined as a syndrome manifested by the occurrence of unpleasant sensations (tingling, burning, pain, pruritus, tingling) in response to stimuli that normally do not not cause such sensations. The triggering factors can be cosmetics, water, cold, heat, temperature variations, wind ... etc.

The physiopathological mechanisms are debated and several hypotheses exist. Sensitive skin can be considered as a decrease of the threshold of cutaneous tolerance. Sensitive skin is linked to abnormalities of the cutaneous nervous system, which becomes hyper-reactive. This hyperreactivity can be modulated by multiple factors. Exposure to cosmetics could be one of the main triggers for sensitive skin, especially for women. This can be explained by the wide use of cosmetics (in France women apply an average of 16 different cosmetics per day), by overconsumption of cosmetics, by exposure to potentially irritating ingredients. Sensitive skin would be less tolerant to the frequent and prolonged use of cosmetics. However, no precise information is available on the actual consumption of cosmetic products in the population with sensitive skin, in particular no data exists concerning the type of products used, the criteria of choice of products, the daily number of products used. and the ingredients contained in these cosmetics

Detailed Description

Objectives are:

To compare the consumption of cosmetics qualitatively and quantitatively in a group of subjects with sensitive skin in the face and scalp, with a group of subjects with non-sensitive skin Study of triggers of sensitive skin Localization of sensitive skin in the face Resonance of sensitive skin Duration of onset of skin sensitivity after application of the cosmetic Use of organic products, formulated for sensitive skin, for children Shopping venues for cosmetics Advice from a professional for the purchase of cosmetics Impact of sensitive skin on the use of cosmetics Budget dedicated to the purchase of cosmetics

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population 150 persons
Condition
  • Sensitive Skin
  • Cosmetic Exposure
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 20, 2019)
150
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 2020
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

Women Between 18 and 65 years old -

Exclusion Criteria:

Men Less than 18 years old More than 65 years old Skin disease on the face: acne, rosacea, eczema Refusal to participate

-

Sex/Gender
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03958968
Other Study ID Numbers SENSICOS (29BRC18.0078)
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party BRENAUT Emilie, University Hospital, Brest
Study Sponsor University Hospital, Brest
Collaborators Not Provided
Investigators Not Provided
PRS Account University Hospital, Brest
Verification Date May 2019