Clinical trial NCT04593706: Comparison of the Efficacy of Different Steroids in the Treatment of Abnormal Scars (Keloids, Hypertrophic Scars)
Official title: Comparison of the Efficacy of Different Steroids in the Treatment of Abnormal Scars (Keloids, Hypertrophic Scars)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Keloid
Hypertrophic Scar
Scars
Scarring
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2020-10-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient and Observer Scar Assessment Scale (POSAS)
timeFrame: enrollment, data will be reported through study completion an average of 1 year
measure: Patient and Observer Scar Assessment Scale (POSAS)
timeFrame: 3 months post last treatment, data will be reported through study completion an average of 1 year
measure: Patient and Observer Scar Assessment Scale (POSAS)
timeFrame: 6 months post last treatment, data will be reported through study completion an average of 1 year
Secondary outcomes:
measure: Visual analogue scale (pain scale)
timeFrame: at each of the three treatment appointments, data will be reported through study completion an average of 1 year
measure: Dermatologist's assessment
timeFrame: 3 months post last treatment, data will be reported through study completion an average of 1 year
measure: 3D camera
timeFrame: 3 months post last treatment, data will be reported through study completion an average of 1 year
measure: Participant's assessment
timeFrame: 3 months post last treatment, data will be reported through study completion an average of 1 year
measure: Dermatologist's assessment
timeFrame: 6 months post last treatment, data will be reported through study completion an average of 1 year
measure: 3D camera
timeFrame: 6 months post last treatment, data will be reported through study completion an average of 1 year
measure: Participant's assessment
timeFrame: 6 months post last treatment, data will be reported through study completion an average of 1 year
Other outcomes:
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