Hypertrophic ScarsPhase 2/3NCT04532840
Effect of Cryotherpy on Hypertrophic Scar
A Phase 2/3 study testing cryotherapy (Gymna Cryoflow ICE-CT) and Exercising, Positioning and splinting, Pressure Therapy and Massage in people with Hypertrophic Scars, run by Zakria Mowafy at 1 site in Egypt.
Trial summary
Purpose of the study: The purpose of the study is to evaluate the therapeutic effect of cryotherpy in treating hypertrophic scar. It will be hypothesized that: Cryotherapy may not have an effect on hypertrophic scar. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Hypertrophic Scars
- What is being tested?
- cryotherapy (Gymna Cryoflow ICE-CT) and Exercising, Positioning and splinting, Pressure Therapy and Massage
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Apr 2019to 1 Oct 2020
- Phase
- Phase 2/3
- 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 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age range between 20- 40 years.
- Both sexes will participate in the study.
- All patients participated will begin treatment program one month after injury depending on injury characteristics.
- All patients enrolled to the study will have their informed consent.
Who cannot join
- Diabetes mellitus.
- Individuals with cardiopulmonary conditions.
- Individuals undergoing radiation therapy or chemotherapy.
- Hepatic or pancreatic diseases.
- Sensory impairment
Trial locations and contacts
1 site in 1 country.
About this study
Purpose of the study:
The purpose of the study is to evaluate the therapeutic effect of cryotherpy in treating hypertrophic scar.
It will be hypothesized that:
Cryotherapy may not have an effect on hypertrophic scar.
Read the detailed description
The potential of cryotherapy application in vitro data indicated that using freezing treatment on VFFs + TGF-β1 (myofibroblast) modulated ECM turnover toward antifibrosis and normalization, attenuated myofibroblast differentiation, reduced cell migration, and weakened the contractile activity. On both VFFs ± TGF-β1, freezing treatment raised LP regeneration (HAS1, decorin).
The findings indicate that cryotherapy may play a protective role in scar formation and contribute to lamina regeneration.
Furthermore the need of this study was developed from the lack in the quantitative knowledge and information in the published studies about the effect of cryotherapy on hypertrophic scar.
This study will be designed to provide a guideline about the effect of effect of cryotherapy on hypertrophic scar height, thickness and discoloration, and to assist in planning an ideal treatment regimen for reducing hypertrophic scar.
Delimitations:
This study will be delimited in the following aspects:
- Subjects: Sixty patients suffering from hypertrophic scar will be randomly divided into two equal groups each one has 30 patients.
- Equipment and tools:
2.1. Measurement equipment: Vancouver scar scale. MAPS (Matching Assessment of Scars and Photographs). 2.2. Therapeutic equipment: Gymna Cryoflow ICE-CT. Temperature resistant polymide tape (48 wide).
Hypothesis:
It will be hypothesized that:
Cryotherapy may not have an effect on hypertrophic scar.
Basic Assumptions:
It will be assumed that:
- All patients will receive the same kinds of medication and the same nursing care.
- All subjects are free from any chronic disease.
- All subjects will continue in the study.
- All patients will follow the instructions during the treatment
- Conditions
- Hypertrophic Scars
- Being tested
- cryotherapy (Gymna Cryoflow ICE-CT), Exercising, Positioning and splinting, Pressure Therapy and Massage
- Medical subject headings
- Cicatrix, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cryotherapy (Gymna Cryoflow ICE-CT)Device
Also called Gymna Cryoflow ICE-CT
Cryotherapy (also called cryoablation) method was produced by James Arnot in England in 1945 to reduce the size of cancerous cells based on the theory that cold blood cells destroy the cells. Campbell White of New York City used cryotherapy as the first dermatological indication in early-stage epithelioma patients in 1890. Later in 1907, Whitehouse described the use of this method in diferent diseases such as pigmented nevus and lupus. In addition, he has published a case series of skin cancers in different face regions.
Exercising, Positioning and splinting, Pressure Therapy and MassageOther
Exercising, Positioning and splinting, Pressure Therapy and Massage
| Study group | Role | What they receive |
|---|---|---|
| Group A: (control group) | Active comparator | This group includes 30 patients will receive routine medical treatment and routine physical therapy as (Exercising, Positioning and splinting, Pressure Therapy and Massage). Receives: Other: Exercising, Positioning and splinting, Pressure Therapy and Massage |
| Group B: (Study group) | Experimental | This group includes 30 patients will receive cryotherapy (at least 10 minutes at -14 degree , 2 sessions per week , for 10 weeks ) in addition to routine medical and physical therapy treatment. Receives: Device: cryotherapy (Gymna Cryoflow ICE-CT); Other: Exercising, Positioning and splinting, Pressure Therapy and Massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
scar height
The potential of cryotherapy application in vitro data indicated that using freezing treatment on scar decrease its height
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2020
- Study start15 Apr 2019
- Primary completion15 Sep 2020 (estimated)
- Study completion1 Oct 2020 (estimated)
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 Hypertrophic ScarsStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study will be delimited in the following aspects: 1. Subjects: Sixty patients suffering from hypertrophic scar will be randomly divided into two equal groups each one has 30 patients. 2. Equipment and tools: 2.1. Measurement equipment: Vancouver scar scale. MAPS (Matching Assessment of Scars and Photographs) (Masters et al., 2006). 2.2. Therapeutic equipment: Gymna Cryoflow ICE-CT. Temperature resistant polymide tape (48 wide)
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zakria Mowafy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zakria Mowafy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04532840
- Sponsor's protocol ID
- P.t.REC/012/002266
- Status last verified
- Aug 2020
- First submitted
- 18 Aug 2020
- Last updated
- 31 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Arno AI, Gauglitz GG, Barret JP, Jeschke MG. Up-to-date approach to manage keloids and hypertrophic scars: a useful guide. Burns. 2014 Nov;40(7):1255-66. doi: 10.1016/j.burns.2014.02.011. Epub 2014 Apr 24.
PubMed 24767715Atiyeh BS, Hayek SN, Gunn SW. New technologies for burn wound closure and healing--review of the literature. Burns. 2005 Dec;31(8):944-56. doi: 10.1016/j.burns.2005.08.023. Epub 2005 Nov 4.
PubMed 16274932
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cryotherpy on Hypertrophic Scar
- ClinicalTrials.gov ID
- NCT04532840
- Acronym / sponsor ID
- P.t.REC/012/002266
- Conditions
- Hypertrophic Scars
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Zakria MowafyUniversity, hospital or other
- Study start
- 15 Apr 2019 (actual)
- Primary completion
- 15 Sep 2020 (estimated)
- Study completion
- 1 Oct 2020 (estimated)
- First posted
- 31 Aug 2020 (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.
Purpose of the study:
The purpose of the study is to evaluate the therapeutic effect of cryotherpy in treating hypertrophic scar.
It will be hypothesized that:
Cryotherapy may not have an effect on hypertrophic scar.
Detailed description
The potential of cryotherapy application in vitro data indicated that using freezing treatment on VFFs + TGF-β1 (myofibroblast) modulated ECM turnover toward antifibrosis and normalization, attenuated myofibroblast differentiation, reduced cell migration, and weakened the contractile activity. On both VFFs ± TGF-β1, freezing treatment raised LP regeneration (HAS1, decorin).
The findings indicate that cryotherapy may play a protective role in scar formation and contribute to lamina regeneration.
Furthermore the need of this study was developed from the lack in the quantitative knowledge and information in the published studies about the effect of cryotherapy on hypertrophic scar.
This study will be designed to provide a guideline about the effect of effect of cryotherapy on hypertrophic scar height, thickness and discoloration, and to assist in planning an ideal treatment regimen for reducing hypertrophic scar.
Delimitations:
This study will be delimited in the following aspects:
- Subjects: Sixty patients suffering from hypertrophic scar will be randomly divided into two equal groups each one has 30 patients.
- Equipment and tools:
2.1. Measurement equipment: Vancouver scar scale. MAPS (Matching Assessment of Scars and Photographs). 2.2. Therapeutic equipment: Gymna Cryoflow ICE-CT. Temperature resistant polymide tape (48 wide).
Hypothesis:
It will be hypothesized that:
Cryotherapy may not have an effect on hypertrophic scar.
Basic Assumptions:
It will be assumed that:
- All patients will receive the same kinds of medication and the same nursing care.
- All subjects are free from any chronic disease.
- All subjects will continue in the study.
- All patients will follow the instructions during the treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study will be delimited in the following aspects: 1. Subjects: Sixty patients suffering from hypertrophic scar will be randomly divided into two equal groups each one has 30 patients. 2. Equipment and tools: 2.1. Measurement equipment: Vancouver scar scale. MAPS (Matching Assessment of Scars and Photographs) (Masters et al., 2006). 2.2. Therapeutic equipment: Gymna Cryoflow ICE-CT. Temperature resistant polymide tape (48 wide)
| Arm | Type | Receives |
|---|---|---|
| Group A: (control group) | Active comparator | Other: Exercising, Positioning and splinting, Pressure Therapy and MassageThis group includes 30 patients will receive routine medical treatment and routine physical therapy as (Exercising, Positioning and splinting, Pressure Therapy and Massage). |
| Group B: (Study group) | Experimental | Device: cryotherapy (Gymna Cryoflow ICE-CT), Other: Exercising, Positioning and splinting, Pressure Therapy and MassageThis group includes 30 patients will receive cryotherapy (at least 10 minutes at -14 degree , 2 sessions per week , for 10 weeks ) in addition to routine medical and physical therapy treatment. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age range between 20- 40 years.
- Both sexes will participate in the study.
- All patients participated will begin treatment program one month after injury depending on injury characteristics.
- All patients enrolled to the study will have their informed consent.
Key exclusion criteria (5 listed)
- Diabetes mellitus.
- Individuals with cardiopulmonary conditions.
- Individuals undergoing radiation therapy or chemotherapy.
- Hepatic or pancreatic diseases.
- Sensory impairment
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 |
|---|---|---|
| cryotherapy (Gymna Cryoflow ICE-CT)Also: Gymna Cryoflow ICE-CTCryotherapy (also called cryoablation) method was produced by James Arnot in England in 1945 to reduce the size of cancerous cells based on the theory that cold blood cells destroy the cells. Campbell White of New York City used cryotherapy as the first dermatological indication in early-stage epithelioma patients in 1890. Later in 1907, Whitehouse described the use of this method in diferent diseases such as pigmented nevus and lupus. In addition, he has published a case series of skin cancers in different face regions. | Device | Group B: (Study group) |
| Exercising, Positioning and splinting, Pressure Therapy and MassageExercising, Positioning and splinting, Pressure Therapy and Massage | Other | Group A: (control group), Group B: (Study group) |
Primary outcome
scar height
Time frame: 3 months
The potential of cryotherapy application in vitro data indicated that using freezing treatment on scar decrease its height
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2020.
- Background: PubMed 24767715Arno AI, Gauglitz GG, Barret JP, Jeschke MG. Up-to-date approach to manage keloids and hypertrophic scars: a useful guide. Burns. 2014 Nov;40(7):1255-66. doi: 10.1016/j.burns.2014.02.011. Epub 2014 Apr 24.
- Background: PubMed 16274932Atiyeh BS, Hayek SN, Gunn SW. New technologies for burn wound closure and healing--review of the literature. Burns. 2005 Dec;31(8):944-56. doi: 10.1016/j.burns.2005.08.023. Epub 2005 Nov 4.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing cryotherapy (Gymna Cryoflow ICE-CT) and Exercising, Positioning and splinting, Pressure Therapy and Massage in people with Hypertrophic Scars, run by Zakria Mowafy at 1 site in Egypt.
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 4 inclusion and 5 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 31 Aug 2020. 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 Egypt. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
scar height (time frame: 3 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 NCT04532840, 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 31 Aug 2020.