Sensitive SkinSENSICOSNCT03958968
Impact of Exposure to Cosmetics on Sensitive Skin
An observational study of Sensitive Skin and Cosmetic Exposure, run by University Hospital, Brest at 2 sites in France.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Sensitive Skin, Cosmetic Exposure
- How many people
- 161 participants
- Where
- 2 sitesFrance
- Study dates
- 9 Apr 2019to 25 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Adult, Older adult
Study population: 150 persons
Who may be able to join
- Women Between 18 and 65 years old -
Who cannot join
- Men Less than 18 years old More than 65 years old Skin disease on the face: acne, rosacea, eczema Refusal to participate
- -
Trial locations and contacts
2 sites in 1 country.
France2 sites
Laboratory Interaction Neurons Keratinocytes
Brest
Laboratory LINK
Brest
About this study
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
Read the 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
- Conditions
- Sensitive Skin, Cosmetic Exposure
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: during the inclusion visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2019
- Study start9 Apr 2019
- Primary completion25 Sep 2019
- Study completion25 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sensitive SkinStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03958968
- Sponsor's protocol ID
- SENSICOS (29BRC18.0078)
- Acronym
- SENSICOS
- Status last verified
- Jan 2021
- First submitted
- 20 May 2019
- Last updated
- 7 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Exposure to Cosmetics on Sensitive Skin
- ClinicalTrials.gov ID
- NCT03958968
- Acronym / sponsor ID
- SENSICOS / SENSICOS (29BRC18.0078)
- Conditions
- Sensitive Skin, Cosmetic Exposure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 9 Apr 2019 (actual)
- Primary completion
- 25 Sep 2019 (actual)
- Study completion
- 25 Sep 2019 (actual)
- First posted
- 22 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- 150 persons
Key inclusion criteria (1 listed)
- Women Between 18 and 65 years old -
Key exclusion criteria (2 listed)
- Men Less than 18 years old More than 65 years old Skin disease on the face: acne, rosacea, eczema Refusal to participate
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sensitive Skin and Cosmetic Exposure, run by University Hospital, Brest at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of cosmetics use between subjects with and without sensitive skin (time frame: during the inclusion visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2022; AzTrials last refreshed its copy on 7 Nov 2026.