Keloids ScarsKELOIDS SCARSNCT02886091
Observational Study of Keloids Scars Treated by Shaving and Cryosurgery
An observational study of Keloids Scars, run by University Hospital, Brest at 1 site in France.
Trial summary
Treatment of keloids scars is difficult and controversial. These keloids have a functional and aesthetic impact. A lot of treatment are described with a lot of relapses and aggravation. Authors report outcomes of the treatment with shaving and cryosurgery Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Keloids Scars
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2014to Aug 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Keloids scars
Who may be able to join
- keloids scars
- treatment of shaving and cryosurgery
Who cannot join
- immunosuppressive therapy
- chemotherapy
Trial locations and contacts
1 site in 1 country.
Alexandra Trimaille contact
France1 site, 1 recruiting
- Recruiting
CHRU de Brest
Brest, 29609
Alexandra Trimaille
About this study
Treatment of keloids scars is difficult and controversial. These keloids have a functional and aesthetic impact. A lot of treatment are described with a lot of relapses and aggravation. Authors report outcomes of the treatment with shaving and cryosurgery
- Conditions
- Keloids Scars
- Keywords
- Keloids, Shaving, Ears, Cryosurgery, Hypertrophic scars
- Medical subject headings
- Keloid, Cicatrix, Hypertrophic
What is being measured
The primary outcome is the main question the study is designed to answer.
size scar
reduction size scar
Measured: Inclusion and one years after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2016 (estimated)
- Study startAug 2014
- Primary completionAug 2019 (estimated)
- Study completionAug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Keloids ScarsStudies 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
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexandra Trimaille, Study director, CHRU de Brest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02886091
- Sponsor's protocol ID
- KELOIDS SCARS
- Acronym
- KELOIDS SCARS
- Status last verified
- May 2019
- First submitted
- 29 Aug 2016
- Last updated
- 9 May 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Keloids Scars Treated by Shaving and Cryosurgery
- ClinicalTrials.gov ID
- NCT02886091
- Acronym / sponsor ID
- KELOIDS SCARS / KELOIDS SCARS
- Conditions
- Keloids Scars
- Keywords
- Keloids, Shaving, Ears, Cryosurgery, Hypertrophic scars
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Aug 2019 (estimated)
- First posted
- 1 Sep 2016 (estimated)
- 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.
Treatment of keloids scars is difficult and controversial. These keloids have a functional and aesthetic impact. A lot of treatment are described with a lot of relapses and aggravation. Authors report outcomes of the treatment with shaving and cryosurgery
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Keloids scars
Key inclusion criteria (2 listed)
- keloids scars
- treatment of shaving and cryosurgery
Key exclusion criteria (2 listed)
- immunosuppressive therapy
- chemotherapy
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
size scar
Time frame: Inclusion and one years after
reduction size scar
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2019.
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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.
Alexandra Trimaille contact
Alexandra Trimaille study director
CHRU de Brest
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Keloids Scars, run by University Hospital, Brest at 1 site 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 2 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: status not confirmed, as of the sponsor's last update on 9 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexandra Trimaille (alexandra.trimaille@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
size scar (time frame: Inclusion and one years after). 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 9 May 2019.