Efficacy and Safety of Fractional CO2 Laser Combined With Intralesional Insulin, Botulinum Toxin or Triamcinolone Acetonide in the Treatment of Keloid: A Clinical, Dermoscopic and Immunohistochemical Study.

Phase 1

Not yet recruiting

• Conditions: Keloid
• Interventions: Drug: Triamcinolone acetonide group; Drug: Insulin group; Drug: Botulinum toxin group

• Registration Number: NCT06230146
• Lead Sponsor: Assiut University

Brief Summary

Keloids are macroscopic cutaneous scarring that result from disturbance of wound healing, that occurs on predisposed individuals .

Keloid shows a kind of over-healing, producing over abundant wound matrix responsible for raised, inflexible red scar tissue, that causes pain and itching .

Detailed Description

Multiple hypotheses have been proposed for keloid formation. Though the pathogenesis of keloids is not fully understood, it involves the dysregulation of complex inflammatory pathways .

Several studies reported that IGF-IR was overexpressed in keloid fibroblasts . Current treatment options include intralesional and topical therapies, surgical interventions, radiation, and laser-based therapies.

Intralesional corticosteroid is the most commonly used nonsurgical treatment for keloids . Fractional laser combined triamcinolone acetonide with may minimize collagen production by decreasing fibroblast activity, with a low recurrence rate of 15.4%, which is superior to each modality.

In recent years, physicians were using botulinum toxin A (BTX-A) as a modality for prevention and treatment of keloids. Botulinum toxin type A, isolated from Clostridium botulinum, is a potent neurotoxin that blocks neuromuscular transmission. It has been shown to improve scar cosmesis by decreasing tension on healing wound edges.

The role of topical insulin in wound healing has been under search in literature since 1970s .

Zhang et al. explored the effect of local insulin injection on systemic blood glucose level and wound healing in patients with diabetic foot ulcer.

As far as the investigatorrs are aware, this is the first study to assess the effectiveness and safety of intralesional insulin for the treatment of keloid.

Study Timeline

• Study First Submitted: 2023-12-22
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-19
• Last Update Submitted: 2024-01-19
• Study First Posted: 2024-01-30
• Last Update Posted: 2024-01-30
• Study Start: 2024-05-01
• Primary Completion: 2026-01-01
• Study Completion: 2026-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• Patients aged equal or more than 10 years old
• with keloids diagnosed clinically
• with any size less than 10 cm2

Exclusion Criteria

• Pregnancy
• Hypertrophic scars
• Diabetes mellitus
• Kidney or liver disease
• Active infection at site of lesion
• Lesions suspicious for malignancy
• Patients use medications that reduced tissue healing during the study or in a period less than sex months ago (immunosuppressants and isotretinoin)
• Patients received any treatment for keloid in the last 3 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Triamcinolone acetonide group (control group)	Triamcinolone acetonide group	Group III (control group) (n=15): Fractional ablative laser followed by Triamcinolone acetonide injection. TAC 40 mg/ml will be diluted with normal saline solution 0.9% to the concentration of 20 mg/ml .Maximum drug injected during each session will be 40 mg triamcinolone.
Insulin group	Insulin group	Group I (n=15): Fractional ablative laser followed by Intralesional insulin injection (Human actrapid insulin 100 IU\\ml solution) Dose: injection of 0.1 ml\\cm3 of the lesion avoiding subcutaneous injection as much as possible especially in fatty areas.
Botulinum toxin group	Botulinum toxin group	Group II (n=15): Fractional ablative laser followed by intralesional Botox-A (100 U vacuum-dried powder in a single-use vial for reconstitution diluted in 2 mL of sterile, preservative-free 0.9% saline to constitute a solution at a concentration of 5 U/0.1 mL),It will be injected into the body of the keloid with the help of a 24gauge needle at a distance of 1 cm apart until slight blanching is visible. The dose will be adjusted to 2.5 U/cm3 of the lesion, not exceeding 100 units per session.

Primary Outcome Measures

Name	Time	Method
measure the changes of the level of IGFR1 in keloid before and after different lines of treatment	after 6 months of treatment	immunohistochemical stain

Secondary Outcome Measures

Name	Time	Method
measure the changes in size and pliability of keloids after different lines of treatment	after 6 months of treatment	Vancouver scar scale

Trial Locations

Locations (1)

Assiut University; 🇪🇬 Assiut, Egypt