NCT04593706

Comparison of the Efficacy of Different Steroids in the Treatment of Abnormal Scars (Keloids, Hypertrophic Scars)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Tel-Aviv Sourasky Medical Center · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Keloid
• Hypertrophic Scar
• Scars
• Scarring

Interventions

Type	Name	Description
DRUG	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
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
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
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

Timeline

• Start date: 2020-11-01
• Primary completion: 2021-10-31
• Completion: 2021-10-31
• First posted: 2020-10-20
• Last updated: 2020-10-20