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

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-01

Study Completion Date

2021-10-31

Brief Summary

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Comparison of the Efficacy of Different Steroids in the Treatment of Abnormal Scars (Keloids and hypertrophic Scars)

Detailed Description

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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

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Keloid Hypertrophic Scar Scars Scarring

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

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

Group Type ACTIVE_COMPARATOR

Betamethasone acetate + Betamethasone sodium phosphate

Intervention Type DRUG

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

Intervention Type DRUG

the steroid will be injected to either a keloid or a 1.5 c"m of the 11 c"m hypertrophic scar

Methylprednisolone acetate

Intervention Type DRUG

the steroid will be injected to either a keloid or a 1.5 c"m of the 11 c"m hypertrophic scar

Triamcinolone acetonide

Intervention Type DRUG

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

Group Type ACTIVE_COMPARATOR

Betamethasone acetate + Betamethasone sodium phosphate

Intervention Type DRUG

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

Intervention Type DRUG

the steroid will be injected to either a keloid or a 1.5 c"m of the 11 c"m hypertrophic scar

Methylprednisolone acetate

Intervention Type DRUG

the steroid will be injected to either a keloid or a 1.5 c"m of the 11 c"m hypertrophic scar

Triamcinolone acetonide

Intervention Type DRUG

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

Intervention Type DRUG

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

Intervention Type DRUG

Methylprednisolone acetate

the steroid will be injected to either a keloid or a 1.5 c"m of the 11 c"m hypertrophic scar

Intervention Type DRUG

Triamcinolone acetonide

the steroid will be injected to either a keloid or a 1.5 c"m of the 11 c"m hypertrophic scar

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 20 participants with at least 4 keloids
* 20 participants with a hypertrophic scar of at least 11 cm length

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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0542-19-TLV

Identifier Type: -

Identifier Source: org_study_id

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