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

Tel Aviv Sourasky Medical Center

Status: Unknown

Conditions: Scars; Keloid; Scarring; Hypertrophic Scar

Treatments: Drug: Dexamethasone sodium phosphate; Drug: Methylprednisolone acetate; Drug: Triamcinolone acetonide; Drug: Betamethasone acetate + Betamethasone sodium phosphate

Study type: Interventional

Funder types: Other

Identifiers

NCT04593706

0542-19-TLV

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

40 participants in 2 patient groups

keloids

Active Comparator group

Description:

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

Treatment:

Drug: Triamcinolone acetonide

Drug: Dexamethasone sodium phosphate

Drug: Methylprednisolone acetate

Drug: Betamethasone acetate + Betamethasone sodium phosphate

hypertrophic scars

Active Comparator group

Description:

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

Treatment:

Drug: Triamcinolone acetonide

Drug: Dexamethasone sodium phosphate

Drug: Methylprednisolone acetate

Drug: Betamethasone acetate + Betamethasone sodium phosphate