Comparison of the Efficacy of Different Steroids in the Treatment of Abnormal Scars (Keloids, Hypertrophic Scars)
NCT ID: NCT04593706
Last Updated: 2020-10-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2020-11-01
2021-10-31
Brief Summary
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Detailed Description
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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
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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keloids
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
Betamethasone acetate + Betamethasone sodium phosphate
the steroid will be injected to either a keloid or a 1.5 c"m of the 11 c"m hypertrophic scar
Dexamethasone sodium phosphate
the steroid will be injected to either a keloid or a 1.5 c"m of the 11 c"m hypertrophic scar
Methylprednisolone acetate
the steroid will be injected to either a keloid or a 1.5 c"m of the 11 c"m hypertrophic scar
Triamcinolone acetonide
the steroid will be injected to either a keloid or a 1.5 c"m of the 11 c"m hypertrophic scar
hypertrophic scars
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
Betamethasone acetate + Betamethasone sodium phosphate
the steroid will be injected to either a keloid or a 1.5 c"m of the 11 c"m hypertrophic scar
Dexamethasone sodium phosphate
the steroid will be injected to either a keloid or a 1.5 c"m of the 11 c"m hypertrophic scar
Methylprednisolone acetate
the steroid will be injected to either a keloid or a 1.5 c"m of the 11 c"m hypertrophic scar
Triamcinolone acetonide
the steroid will be injected to either a keloid or a 1.5 c"m of the 11 c"m hypertrophic scar
Interventions
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Betamethasone acetate + Betamethasone sodium phosphate
the steroid will be injected to either a keloid or a 1.5 c"m of the 11 c"m hypertrophic scar
Dexamethasone sodium phosphate
the steroid will be injected to either a keloid or a 1.5 c"m of the 11 c"m hypertrophic scar
Methylprednisolone acetate
the steroid will be injected to either a keloid or a 1.5 c"m of the 11 c"m hypertrophic scar
Triamcinolone acetonide
the steroid will be injected to either a keloid or a 1.5 c"m of the 11 c"m hypertrophic scar
Eligibility Criteria
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Inclusion Criteria
* 20 participants with a hypertrophic scar of at least 11 cm length
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Tel-Aviv Sourasky Medical Center
OTHER_GOV
Responsible Party
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Other Identifiers
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0542-19-TLV
Identifier Type: -
Identifier Source: org_study_id
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