Prospective Evaluation of the Use of Intralesional Cryotherapy for Treatment of Keloid and Hypertrophic Scars
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01994616 |
Recruitment Status :
Completed
First Posted : November 26, 2013
Last Update Posted : November 26, 2013
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment |
---|---|
Keloid Cicatrix, Hypertrophic | Procedure: Intralesional cryotherapy |
Study Type : | Observational |
Actual Enrollment : | 30 participants |
Time Perspective: | Prospective |
Official Title: | Intralesional Cryotherapy for Treatment of Keloid Scars: a Prospective Evaluation |
Study Start Date : | January 2009 |
Actual Primary Completion Date : | January 2011 |
Actual Study Completion Date : | June 2011 |
Group/Cohort | Intervention/treatment |
---|---|
keloid or hypertrophic scars
All patient including all skin types with keloid or hypertrophic disease receiving Intralesional Cryotherapy
|
Procedure: Intralesional cryotherapy
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
Other Name: Cryoneedle (CryoShape, Etgar Group International Ltd, Kfar Saba, Israel) |
- Recurrence [ Time Frame: 0-12 months ]Judgment of recurrence, defined as a growing, pruritic, nodular scar
- Scar elasticity [ Time Frame: 0-12months ]Scar elasticity, measured in two parameters: extension and elasticity
- Scar volume [ Time Frame: 0-12months ]Determined by creating a mold of the scar with dental putty
- Redness (erythema) and pigmentation (melanin), [ Time Frame: 0-12months ]Redness (erythema) and pigmentation (melanin), which were measured using the DermaSpectrometer
- Subjective scar evaluation [ Time Frame: 0-12months ]performed by two experienced medical doctors and the patient using the Patient and Observer Scar Assessment Scale (POSAS). Each item of the POSAS was scored using a 10-step score, in which 10 reflected 'worst scar imaginable' and 1 indicated 'normal skin'

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 10 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- 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
Exclusion Criteria:
- pregnancy
- diabetes mellitus

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01994616
Netherlands | |
VUmc | |
Amsterdam, Noord-Holland, Netherlands, 1081HV |
Principal Investigator: | Michiel CE van Leeuwen, MD | VUmc | |
Study Director: | Frank B Niessen, PhD, MD | Vumc |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Michiel van Leeuwen, Medical Doctor, VU University Medical Center |
ClinicalTrials.gov Identifier: | NCT01994616 |
Other Study ID Numbers: |
12/292 |
First Posted: | November 26, 2013 Key Record Dates |
Last Update Posted: | November 26, 2013 |
Last Verified: | November 2013 |
Keloid, hypertrophic scar |
Keloid Hypertrophy Cicatrix, Hypertrophic Cicatrix Pathological Conditions, Anatomical |
Collagen Diseases Connective Tissue Diseases Fibrosis Pathologic Processes |