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.

NCT06230146 | Not Yet Recruiting Phase 1

• 1 other identifier: ASUH
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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 .

Conditions

Keloid

Outcome Measures

Primary Outcomes (1)

• measure the changes of the level of IGFR1 in keloid before and after different lines of treatment

  immunohistochemical stain

  after 6 months of treatment

Secondary Outcomes (1)

• measure the changes in size and pliability of keloids after different lines of treatment

  after 6 months of treatment

Study Arms (3)

Insulin group

EXPERIMENTAL

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

Botulinum toxin group

EXPERIMENTAL

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

Triamcinolone acetonide group (control group)

EXPERIMENTAL

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

Interventions

Insulin group DRUG

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.

Insulin group

Botulinum toxin group DRUG

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.

Botulinum toxin group

Triamcinolone acetonide group DRUG

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.

Also known as: control group

Triamcinolone acetonide group (control group)

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University

Asyut, Egypt

Location

Related Publications (8)

• Ogawa R. Keloid and Hypertrophic Scars Are the Result of Chronic Inflammation in the Reticular Dermis. Int J Mol Sci. 2017 Mar 10;18(3):606. doi: 10.3390/ijms18030606.

  PMID: 28287424 BACKGROUND

• Ohtsuru A, Yoshimoto H, Ishihara H, Namba H, Yamashita S. Insulin-like growth factor-I (IGF-I)/IGF-I receptor axis and increased invasion activity of fibroblasts in keloid. Endocr J. 2000 Mar;47 Suppl:S41-4. doi: 10.1507/endocrj.47.supplmarch_s41.

  PMID: 10890181 BACKGROUND

• Betarbet U, Blalock TW. Keloids: A Review of Etiology, Prevention, and Treatment. J Clin Aesthet Dermatol. 2020 Feb;13(2):33-43. Epub 2020 Feb 1.

  PMID: 32308783 BACKGROUND

• Walsh LA, Wu E, Pontes D, Kwan KR, Poondru S, Miller CH, Kundu RV. Keloid treatments: an evidence-based systematic review of recent advances. Syst Rev. 2023 Mar 14;12(1):42. doi: 10.1186/s13643-023-02192-7.

  PMID: 36918908 BACKGROUND

• Thornton NJ, Garcia BA, Hoyer P, Wilkerson MG. Keloid Scars: An Updated Review of Combination Therapies. Cureus. 2021 Jan 30;13(1):e12999. doi: 10.7759/cureus.12999.

  PMID: 33542883 BACKGROUND

• Gassner HG, Sherris DA, Otley CC. Treatment of facial wounds with botulinum toxin A improves cosmetic outcome in primates. Plast Reconstr Surg. 2000 May;105(6):1948-53; discussion 1954-5. doi: 10.1097/00006534-200005000-00005.

  PMID: 10839391 BACKGROUND

• Wang J, Xu J. Effects of Topical Insulin on Wound Healing: A Review of Animal and Human Evidences. Diabetes Metab Syndr Obes. 2020 Mar 13;13:719-727. doi: 10.2147/DMSO.S237294. eCollection 2020.

  PMID: 32214835 BACKGROUND

• Zhang Z, Lv L. Effect of local insulin injection on wound vascularization in patients with diabetic foot ulcer. Exp Ther Med. 2016 Feb;11(2):397-402. doi: 10.3892/etm.2015.2917. Epub 2015 Dec 8.

  PMID: 26893621 BACKGROUND

MeSH Terms

Conditions

Keloid

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Doaa Samir, Professor

CONTACT

01143387171; doaasamir1@yahoo.com

Eman Fathy, lecturer

CONTACT

+201002258614; emanfathey639@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: double blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Model Details: 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 (10) avoiding subcutaneous injection as much as possible especially in fatty areas. 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. 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 .

Study Record Dates

• First Submitted: December 22, 2023
• First Posted: January 30, 2024
• Study Start: May 1, 2024
• Primary Completion: January 1, 2026
• Study Completion: May 1, 2026
• Last Updated: January 30, 2024

Record last verified: 2024-01

Locations

EG (1)