A Phase 1/2 interventional study of Insulin group and Botulinum toxin group in Keloid, sponsored by Assiut University. Not yet recruiting at 1 site in Egypt. Open to participants aged 10 Years and older. Per ClinicalTrials.gov, last updated 2024-01-30.
Sponsored by Assiut University · Phase 1/2, Interventional, and Treatment
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 .
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.
138 studies on the registry are indexed under Keloid; 26 are open to participants now.
This study's planned enrollment of 45 is above the median of 30 across 109 interventional studies indexed under Keloid.
Browse Keloid studies →Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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 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.
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.
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
measure the changes of the level of IGFR1 in keloid before and after different lines of treatment
immunohistochemical stain
Time frame: after 6 months of treatment
measure the changes in size and pliability of keloids after different lines of treatment
Vancouver scar scale
Time frame: after 6 months of treatment
Plan to share: Undecided
Start is estimated for May 2024; primary completion for Jan 2026, 20 months later.
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Studies of the drugs tested here: Insulin · Botulinum Toxins · Triamcinolone Acetonide