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.

January 19, 2024 updated by: YSAbdelraheem, Assiut University

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 .

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

45

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Insulin group

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.
Experimental: 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.
Drug: Botulinum toxin group
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.
Experimental: 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.
Drug: Triamcinolone acetonide group
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.
Other Names:
  • control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
after 6 months of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
measure the changes in size and pliability of keloids after different lines of treatment
Time Frame: after 6 months of treatment
Vancouver scar scale
after 6 months of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

December 22, 2023

First Submitted That Met QC Criteria

January 19, 2024

First Posted (Actual)

January 30, 2024

Study Record Updates

Last Update Posted (Actual)

January 30, 2024

Last Update Submitted That Met QC Criteria

January 19, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASUH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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