KeloidNCT04593706
Comparison of the Efficacy of Different Steroids in the Treatment of Abnormal Scars (Keloids, Hypertrophic Scars)
A study testing Betamethasone acetate + Betamethasone sodium phosphate, Dexamethasone sodium phosphate and Methylprednisolone acetate in people with Keloid and Hypertrophic Scar, run by Tel-Aviv Sourasky Medical Center.
Trial summary
Comparison of the Efficacy of Different Steroids in the Treatment of Abnormal Scars (Keloids and hypertrophic Scars) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Keloid, Hypertrophic Scar, Scars
- What is being tested?
- Betamethasone acetate + Betamethasone sodium phosphate, Dexamethasone sodium phosphate and Methylprednisolone acetate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2020to 31 Oct 2021
- Phase
- Interventional
- 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
Who may be able to join
- 20 participants with at least 4 keloids
- 20 participants with a hypertrophic scar of at least 11 cm length
Who cannot join
- current or planned pregnancy
- breastfeeding women
- participants suffering from diabetes mellitus or coagulation disorders
- infection at planned injection sites
- systemic treatment of corticosteroids, 5-fluorouracil
- known allergy to any of the following: Betamethasone acetate + Betamethasone sodium phosphate, Triamcinolone acetonide, Dexamethasone sodium phosphate, Methylprednisolone acetate
About this study
Comparison of the Efficacy of Different Steroids in the Treatment of Abnormal Scars (Keloids and hypertrophic Scars)
Read the detailed description
On a yearly basis, millions develop different skin scarring. These scars are a public reminder of the traumatic incident, past or present disease or a surgery which caused them.
Scarring is a common consequence of wound healing process, and it is one of the most complex biological processes in human. This healing process is affected by numerous factors and thus can be disrupted, leading to pathological scarring.
Pathological scarring is common in people with genetic predisposition, those undergone complex and massive surgeries, burns or those wounded in unsanitary environments. Apart from being aesthetically unpleasant, scars are associated with functional and psychosocial morbidities.
Despite clinical, pathologic and pathogenic differences between keloids and hypertrophic scars, treatments are similar.
Scars have a negative external impact causing social distress and impaired self-image, and as a consequence, low satisfaction rates following surgical and cosmetic procedures.
The first line treatment is monthly intralesional corticosteroid injections with a response rate of 50-100% and recurrence of 50%.
There are a few steroids available and used for abnormal scars treatment, including Celestone chronodose (Betamethasone acetate + Betamethasone sodium phosphate), Dexamethasone sodium phosphate, Methylprednisolone acetate, Methylprednisolone sodium succinate, Methylprednisolone hemisuccinate, Triamcinolone acetonide.
Steroids are different by their hydrophilic properties, potency and half-life, although the half-life of intralesional injections is not known. Inspite of being widely used, there have never been a comparative study of the different steroid treatments.
- Conditions
- Keloid, Hypertrophic Scar, Scars, Scarring
- Being tested
- Betamethasone acetate + Betamethasone sodium phosphate, Dexamethasone sodium phosphate, Methylprednisolone acetate, Triamcinolone acetonide
- Medical subject headings
- Keloid, Cicatrix, Hypertrophic, Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Betamethasone acetate + Betamethasone sodium phosphateDrug
the steroid will be injected to either a keloid or a 1.5 c"m of the 11 c"m hypertrophic scar
Dexamethasone sodium phosphateDrug
the steroid will be injected to either a keloid or a 1.5 c"m of the 11 c"m hypertrophic scar
Methylprednisolone acetateDrug
the steroid will be injected to either a keloid or a 1.5 c"m of the 11 c"m hypertrophic scar
Triamcinolone acetonideDrug
the steroid will be injected to either a keloid or a 1.5 c"m of the 11 c"m hypertrophic scar
| Study group | Role | What they receive |
|---|---|---|
| keloids | Active comparator | each patient will be injection by all 4 steroids for comparison patients with 4 or more keloids will be injection with each steroid for different keloid Receives: Drug: Betamethasone acetate + Betamethasone sodium phosphate; Drug: Dexamethasone sodium phosphate; Drug: Methylprednisolone acetate; Drug: Triamcinolone acetonide |
| hypertrophic scars | Active comparator | each patient will be injection by all 4 steroids for comparison patients with a 11 cm hypertrophic scar will be injected by all 4 steroids along the scar with a 1 cm distance between each steroid Receives: Drug: Betamethasone acetate + Betamethasone sodium phosphate; Drug: Dexamethasone sodium phosphate; Drug: Methylprednisolone acetate; Drug: Triamcinolone acetonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient and Observer Scar Assessment Scale (POSAS)
For the Observer Scar Assessment Scale (OSAS), the investigators score the following parameters of each part of the scar on a scale ranging from 1 (normal skin) to 10 (worst scar imagin¬able): 'vascularization', 'pigmentation', 'thickness', 'relief', and 'pliability'. The total score on the OSAS is the sum of the scores of each item, yielding a total score ranging from 6 (best) to 60 (worst). For the patient scar assessment scale (PSAS), the participants used a scale of 1 to 10 to answer questions relating to pain, itching, color, stiffness, irregularity and thickness. The total score on the PSAS was the sum of the scores of each item, yielding a total score ranging from 6 (best) to 60 (worst)
Measured: enrollment, data will be reported through study completion an average of 1 year
Patient and Observer Scar Assessment Scale (POSAS)
For the Observer Scar Assessment Scale (OSAS), the investigators score the following parameters of each part of the scar on a scale ranging from 1 (normal skin) to 10 (worst scar imagin¬able): 'vascularization', 'pigmentation', 'thickness', 'relief', and 'pliability'. The total score on the OSAS is the sum of the scores of each item, yielding a total score ranging from 6 (best) to 60 (worst). For the patient scar assessment scale (PSAS), the participants used a scale of 1 to 10 to answer questions relating to pain, itching, color, stiffness, irregularity and thickness. The total score on the PSAS was the sum of the scores of each item, yielding a total score ranging from 6 (best) to 60 (worst)
Measured: 3 months post last treatment, data will be reported through study completion an average of 1 year
Patient and Observer Scar Assessment Scale (POSAS)
For the Observer Scar Assessment Scale (OSAS), the investigators score the following parameters of each part of the scar on a scale ranging from 1 (normal skin) to 10 (worst scar imagin¬able): 'vascularization', 'pigmentation', 'thickness', 'relief', and 'pliability'. The total score on the OSAS is the sum of the scores of each item, yielding a total score ranging from 6 (best) to 60 (worst). For the patient scar assessment scale (PSAS), the participants used a scale of 1 to 10 to answer questions relating to pain, itching, color, stiffness, irregularity and thickness. The total score on the PSAS was the sum of the scores of each item, yielding a total score ranging from 6 (best) to 60 (worst)
Measured: 6 months post last treatment, data will be reported through study completion an average of 1 year
Secondary outcomes (7)
Visual analogue scale (pain scale)
1 - paineless, 10- extremely painfull
Measured: at each of the three treatment appointments, data will be reported through study completion an average of 1 year
Dermatologist's assessment
0- no change, 1-minor change <5%, 2-Mild change - 25-50%, 3- Moderate Change 50-75%, 4-Significant change > 75%
Measured: 3 months post last treatment, data will be reported through study completion an average of 1 year
3D camera
improvement percentage of scar volume
Measured: 3 months post last treatment, data will be reported through study completion an average of 1 year
Participant's assessment
0- no change, 1-minor change <5%, 2-Mild change - 25-50%, 3- Moderate Change 50-75%, 4-Significant change > 75%
Measured: 3 months post last treatment, data will be reported through study completion an average of 1 year
Dermatologist's assessment
0- no change, 1-minor change <5%, 2-Mild change - 25-50%, 3- Moderate Change 50-75%, 4-Significant change > 75%
Measured: 6 months post last treatment, data will be reported through study completion an average of 1 year
3D camera
improvement percentage of scar volume
Measured: 6 months post last treatment, data will be reported through study completion an average of 1 year
Participant's assessment
0- no change, 1-minor change <5%, 2-Mild change - 25-50%, 3- Moderate Change 50-75%, 4-Significant change > 75%
Measured: 6 months post last treatment, data will be reported through study completion an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study start1 Nov 2020 (estimated)
- Primary completion31 Oct 2021 (estimated)
- Study completion31 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KeloidStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04593706
- Sponsor's protocol ID
- 0542-19-TLV
- Status last verified
- Aug 2020
- First submitted
- 29 Jul 2020
- Last updated
- 20 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Different Steroids in the Treatment of Abnormal Scars (Keloids, Hypertrophic Scars)
- ClinicalTrials.gov ID
- NCT04593706
- Acronym / sponsor ID
- 0542-19-TLV
- Conditions
- Keloid, Hypertrophic Scar, Scars, Scarring
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- 1 Nov 2020 (estimated)
- Primary completion
- 31 Oct 2021 (estimated)
- Study completion
- 31 Oct 2021 (estimated)
- First posted
- 20 Oct 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.
Comparison of the Efficacy of Different Steroids in the Treatment of Abnormal Scars (Keloids and hypertrophic Scars)
Detailed description
On a yearly basis, millions develop different skin scarring. These scars are a public reminder of the traumatic incident, past or present disease or a surgery which caused them.
Scarring is a common consequence of wound healing process, and it is one of the most complex biological processes in human. This healing process is affected by numerous factors and thus can be disrupted, leading to pathological scarring.
Pathological scarring is common in people with genetic predisposition, those undergone complex and massive surgeries, burns or those wounded in unsanitary environments. Apart from being aesthetically unpleasant, scars are associated with functional and psychosocial morbidities.
Despite clinical, pathologic and pathogenic differences between keloids and hypertrophic scars, treatments are similar.
Scars have a negative external impact causing social distress and impaired self-image, and as a consequence, low satisfaction rates following surgical and cosmetic procedures.
The first line treatment is monthly intralesional corticosteroid injections with a response rate of 50-100% and recurrence of 50%.
There are a few steroids available and used for abnormal scars treatment, including Celestone chronodose (Betamethasone acetate + Betamethasone sodium phosphate), Dexamethasone sodium phosphate, Methylprednisolone acetate, Methylprednisolone sodium succinate, Methylprednisolone hemisuccinate, Triamcinolone acetonide.
Steroids are different by their hydrophilic properties, potency and half-life, although the half-life of intralesional injections is not known. Inspite of being widely used, there have never been a comparative study of the different steroid treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| keloids | Active comparator | Drug: Betamethasone acetate + Betamethasone sodium phosphate, Drug: Dexamethasone sodium phosphate, Drug: Methylprednisolone acetate, Drug: Triamcinolone acetonideeach patient will be injection by all 4 steroids for comparison patients with 4 or more keloids will be injection with each steroid for different keloid |
| hypertrophic scars | Active comparator | Drug: Betamethasone acetate + Betamethasone sodium phosphate, Drug: Dexamethasone sodium phosphate, Drug: Methylprednisolone acetate, Drug: Triamcinolone acetonideeach patient will be injection by all 4 steroids for comparison patients with a 11 cm hypertrophic scar will be injected by all 4 steroids along the scar with a 1 cm distance between each steroid |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 20 participants with at least 4 keloids
- 20 participants with a hypertrophic scar of at least 11 cm length
Key exclusion criteria (6 listed)
- current or planned pregnancy
- breastfeeding women
- participants suffering from diabetes mellitus or coagulation disorders
- infection at planned injection sites
- systemic treatment of corticosteroids, 5-fluorouracil
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 |
|---|---|---|
| Betamethasone acetate + Betamethasone sodium phosphatethe steroid will be injected to either a keloid or a 1.5 c"m of the 11 c"m hypertrophic scar | Drug | hypertrophic scars, keloids |
| Dexamethasone sodium phosphatethe steroid will be injected to either a keloid or a 1.5 c"m of the 11 c"m hypertrophic scar | Drug | hypertrophic scars, keloids |
| Methylprednisolone acetatethe steroid will be injected to either a keloid or a 1.5 c"m of the 11 c"m hypertrophic scar | Drug | hypertrophic scars, keloids |
| Triamcinolone acetonidethe steroid will be injected to either a keloid or a 1.5 c"m of the 11 c"m hypertrophic scar | Drug | hypertrophic scars, keloids |
Primary outcome
Patient and Observer Scar Assessment Scale (POSAS)
Time frame: enrollment, data will be reported through study completion an average of 1 year
For the Observer Scar Assessment Scale (OSAS), the investigators score the following parameters of each part of the scar on a scale ranging from 1 (normal skin) to 10 (worst scar imagin¬able): 'vascularization', 'pigmentation', 'thickness', 'relief', and 'pliability'. The total score on the OSAS is the sum of the scores of each item, yielding a total score ranging from 6 (best) to 60 (worst). For the patient scar assessment scale (PSAS), the participants used a scale of 1 to 10 to answer questions relating to pain, itching, color, stiffness, irregularity and thickness. The total score on the PSAS was the sum of the scores of each item, yielding a total score ranging from 6 (best) to 60 (worst)
Patient and Observer Scar Assessment Scale (POSAS)
Time frame: 3 months post last treatment, data will be reported through study completion an average of 1 year
For the Observer Scar Assessment Scale (OSAS), the investigators score the following parameters of each part of the scar on a scale ranging from 1 (normal skin) to 10 (worst scar imagin¬able): 'vascularization', 'pigmentation', 'thickness', 'relief', and 'pliability'. The total score on the OSAS is the sum of the scores of each item, yielding a total score ranging from 6 (best) to 60 (worst). For the patient scar assessment scale (PSAS), the participants used a scale of 1 to 10 to answer questions relating to pain, itching, color, stiffness, irregularity and thickness. The total score on the PSAS was the sum of the scores of each item, yielding a total score ranging from 6 (best) to 60 (worst)
Patient and Observer Scar Assessment Scale (POSAS)
Time frame: 6 months post last treatment, data will be reported through study completion an average of 1 year
For the Observer Scar Assessment Scale (OSAS), the investigators score the following parameters of each part of the scar on a scale ranging from 1 (normal skin) to 10 (worst scar imagin¬able): 'vascularization', 'pigmentation', 'thickness', 'relief', and 'pliability'. The total score on the OSAS is the sum of the scores of each item, yielding a total score ranging from 6 (best) to 60 (worst). For the patient scar assessment scale (PSAS), the participants used a scale of 1 to 10 to answer questions relating to pain, itching, color, stiffness, irregularity and thickness. The total score on the PSAS was the sum of the scores of each item, yielding a total score ranging from 6 (best) to 60 (worst)
7 secondary outcomes
Visual analogue scale (pain scale)
Time frame: at each of the three treatment appointments, data will be reported through study completion an average of 1 year
Dermatologist's assessment
Time frame: 3 months post last treatment, data will be reported through study completion an average of 1 year
3D camera
Time frame: 3 months post last treatment, data will be reported through study completion an average of 1 year
Participant's assessment
Time frame: 3 months post last treatment, data will be reported through study completion an average of 1 year
Dermatologist's assessment
Time frame: 6 months post last treatment, data will be reported through study completion an average of 1 year
3D camera
Time frame: 6 months post last treatment, data will be reported through study completion an average of 1 year
Participant's assessment
Time frame: 6 months post last treatment, data will be reported through study completion an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2020.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Betamethasone acetate + Betamethasone sodium phosphate, Dexamethasone sodium phosphate and Methylprednisolone acetate in people with Keloid and Hypertrophic Scar, run by Tel-Aviv Sourasky Medical Center.
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 6 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 20 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Patient and Observer Scar Assessment Scale (POSAS) (time frame: enrollment, data will be reported through study completion an average of 1 year). The study lists 3 primary outcomes in all. 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 20 Oct 2020.