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.
Trial Snapshot
- Phase
- Phase 1
- Status
- Not yet recruiting
- Sponsor
- Assiut University
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- measure the changes of the level of IGFR1 in keloid before and after different lines of treatment
Study Overview
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 .
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
double blinded
Eligibility Criteria
- Ages
- 10 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Insulin group (Drug)
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.
Intervention: Botulinum toxin group (Drug)
Triamcinolone acetonide group (control 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.
Intervention: Triamcinolone acetonide group (Drug)
Outcomes
Primary Outcomes
measure the changes of the level of IGFR1 in keloid before and after different lines of treatment
Time Frame: after 6 months of treatment
immunohistochemical stain
Secondary Outcomes
- measure the changes in size and pliability of keloids after different lines of treatment(after 6 months of treatment)
Investigators
YSAbdelraheem
principle investigator
Assiut University