KeloidNCT01994616
Prospective Evaluation of the Use of Intralesional Cryotherapy for Treatment of Keloid and Hypertrophic Scars
An observational study of Keloid and Cicatrix, Hypertrophic, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
Trial summary
This prospective evaluation studies the effectiveness of IL cryotherapy in treating keloids and hypertrophic scars in a large population of mixed Fitzpatrick skin types. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Keloid, Cicatrix, Hypertrophic
- What is being tested?
- Intralesional cryotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2009to Jun 2011
- 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 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: A mixed patient population with all Fitzpatrick skin types
Who may be able to join
- Keloids, defined as excessive scar tissue raised above skin level and proliferating beyond the confines of the original lesion
- Hypertrophic scars1 older than 12 months and insensitive to other treatments. Keloids were distinguished from hypertrophic scars based on the clinical judgment of experienced plastic surgeons and on the age of the scar (>1yr)
- A period between previous treatment and IL cryotherapy covered a minimum of 12 weeks
- Patients with all Fitzpatrick17 skin types
- Patients older than 10 years of age
Who cannot join
- pregnancy
- diabetes mellitus
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intralesional Cryotherapy for Treatment of Keloid Scars: a Prospective Evaluation
This prospective evaluation studies the effectiveness of IL cryotherapy in treating keloids and hypertrophic scars in a large population of mixed Fitzpatrick skin types.
Read the detailed description
Intralesional (IL) cryotherapy is a novel treatment for keloids and hypertrophic scars, in which the scar is frozen from inside. Published results are promising, however only Caucasian patient populations have been studied. This prospective evaluation studies the effectiveness of IL cryotherapy in treating keloids and hypertrophic scars in a large population of mixed Fitzpatrick skin types. All patients with keloid or hypertrophic scars meeting inclusion criteria were treated with a liquid nitrogen based device called Cryoshape Scar quality and possible recurrence are assessed pre- and postsurgery (3, 6 and 12 months) with objective devices determine scar color, scar elasticity, scar volume and patient's skin type. In addition, scars are evaluated using the Patient and Observer Scar Assessment Scale.
- Conditions
- Keloid, Cicatrix, Hypertrophic
- Being tested
- Intralesional cryotherapy
- Keywords
- Keloid, hypertrophic scar
- Medical subject headings
- Keloid, Cicatrix, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intralesional cryotherapyProcedure or surgery
Also called Cryoneedle (CryoShape, Etgar Group International Ltd, Kfar Saba, Israel)
Intralesional (IL) cryotherapy is a treatment for keloids and hypertrophic scars, in which the scar is frozen from inside with the use of a cryoneedle
| Study group | Role | What they receive |
|---|---|---|
| keloid or hypertrophic scars | All patient including all skin types with keloid or hypertrophic disease receiving Intralesional Cryotherapy Receives: Procedure: Intralesional cryotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence
Judgment of recurrence, defined as a growing, pruritic, nodular scar
Measured: 0-12 months
Secondary outcomes (1)
Scar elasticity
Scar elasticity, measured in two parameters: extension and elasticity
Measured: 0-12months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2013 (estimated)
- Study startJan 2009
- Primary completionJan 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for KeloidStudies of the same condition, open and under way.
- More trials run by Amsterdam UMC, location VUmcThe 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
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Collaborators
- Red Cross Hospital Beverwijk
- Responsible party
- Principal investigator, Michiel van Leeuwen, Amsterdam UMC, location VUmc
- Investigators
- Michiel CE van Leeuwen, MD, Principal investigator, VUmcFrank B Niessen, PhD, MD, Study director, Vumc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01994616
- Sponsor's protocol ID
- 12/292
- Status last verified
- Nov 2013
- First submitted
- 19 Nov 2013
- Last updated
- 26 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Har-Shai Y, Amar M, Sabo E. Intralesional cryotherapy for enhancing the involution of hypertrophic scars and keloids. Plast Reconstr Surg. 2003 May;111(6):1841-52. doi: 10.1097/01.PRS.0000056868.42679.05.
PubMed 12711943van Leeuwen MCE, van der Wal MBA, Bulstra AJ, Galindo-Garre F, Molier J, van Zuijlen PPM, van Leeuwen PAM, Niessen FB. Intralesional cryotherapy for treatment of keloid scars: a prospective study. Plast Reconstr Surg. 2015 Feb;135(2):580-589. doi: 10.1097/PRS.0000000000000911.
PubMed 25626801
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intralesional Cryotherapy for Treatment of Keloid Scars: a Prospective Evaluation
- ClinicalTrials.gov ID
- NCT01994616
- Acronym / sponsor ID
- 12/292
- Conditions
- Keloid, Cicatrix, Hypertrophic
- Keywords
- Keloid, hypertrophic scar
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Collaborators
- Red Cross Hospital Beverwijk
- Study start
- Jan 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 26 Nov 2013 (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.
This prospective evaluation studies the effectiveness of IL cryotherapy in treating keloids and hypertrophic scars in a large population of mixed Fitzpatrick skin types.
Detailed description
Intralesional (IL) cryotherapy is a novel treatment for keloids and hypertrophic scars, in which the scar is frozen from inside. Published results are promising, however only Caucasian patient populations have been studied. This prospective evaluation studies the effectiveness of IL cryotherapy in treating keloids and hypertrophic scars in a large population of mixed Fitzpatrick skin types. All patients with keloid or hypertrophic scars meeting inclusion criteria were treated with a liquid nitrogen based device called Cryoshape Scar quality and possible recurrence are assessed pre- and postsurgery (3, 6 and 12 months) with objective devices determine scar color, scar elasticity, scar volume and patient's skin type. In addition, scars are evaluated using the Patient and Observer Scar Assessment Scale.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| keloid or hypertrophic scars | – | Procedure: Intralesional cryotherapyAll patient including all skin types with keloid or hypertrophic disease receiving Intralesional Cryotherapy |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A mixed patient population with all Fitzpatrick skin types
Key inclusion criteria (5 listed)
- Keloids, defined as excessive scar tissue raised above skin level and proliferating beyond the confines of the original lesion
- Hypertrophic scars1 older than 12 months and insensitive to other treatments. Keloids were distinguished from hypertrophic scars based on the clinical judgment of experienced plastic surgeons and on the age of the scar (>1yr)
- A period between previous treatment and IL cryotherapy covered a minimum of 12 weeks
- Patients with all Fitzpatrick17 skin types
- Patients older than 10 years of age
Key exclusion criteria (2 listed)
- pregnancy
- diabetes mellitus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intralesional cryotherapyAlso: Cryoneedle (CryoShape, Etgar Group International Ltd, Kfar Saba, Israel)Intralesional (IL) cryotherapy is a treatment for keloids and hypertrophic scars, in which the scar is frozen from inside with the use of a cryoneedle | Procedure or surgery | keloid or hypertrophic scars |
Primary outcome
Recurrence
Time frame: 0-12 months
Judgment of recurrence, defined as a growing, pruritic, nodular scar
1 secondary outcome
Scar elasticity
Time frame: 0-12months
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 26 Nov 2013.
- Background: PubMed 12711943Har-Shai Y, Amar M, Sabo E. Intralesional cryotherapy for enhancing the involution of hypertrophic scars and keloids. Plast Reconstr Surg. 2003 May;111(6):1841-52. doi: 10.1097/01.PRS.0000056868.42679.05.
- Derived from this study: PubMed 25626801van Leeuwen MCE, van der Wal MBA, Bulstra AJ, Galindo-Garre F, Molier J, van Zuijlen PPM, van Leeuwen PAM, Niessen FB. Intralesional cryotherapy for treatment of keloid scars: a prospective study. Plast Reconstr Surg. 2015 Feb;135(2):580-589. doi: 10.1097/PRS.0000000000000911.
- homepage VU medical center, hospital Amsterdam, the NetherlandsLink provided by the sponsor.
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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.
Michiel CE van Leeuwen, MD principal investigator
VUmc
Frank B Niessen, PhD, MD study director
Vumc
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 Keloid and Cicatrix, Hypertrophic, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
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 5 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 26 Nov 2013. 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 Netherlands. 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?
Recurrence (time frame: 0-12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01994616, which also lists 2 linked publications.
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 26 Nov 2013.