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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03958968
Other study ID # SENSICOS (29BRC18.0078)
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 9, 2019
Est. completion date September 25, 2019

Study information

Verified date January 2021
Source University Hospital, Brest
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


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


Recruitment information / eligibility

Status Completed
Enrollment 161
Est. completion date September 25, 2019
Est. primary completion date September 25, 2019
Accepts healthy volunteers
Gender Female
Age group 18 Years to 65 Years
Eligibility 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 -

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Laboratory Interaction Neurons Keratinocytes Brest
France Laboratory LINK Brest

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Comparison of cosmetics use between subjects with and without sensitive skin 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 during the inclusion visit
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Completed NCT03081403 - Quantitative Sensory Testing in Subjects With Sensitive Skin or Not N/A