KeloidPhase 1/2NCT06230146
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.
A Phase 1/2 study testing Insulin group, Botulinum toxin group and Triamcinolone acetonide group in people with Keloid, run by Assiut University at 1 site in Egypt.
Trial 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 . Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Keloid
- What is being tested?
- Insulin group, Botulinum toxin group and Triamcinolone acetonide group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2024to 1 May 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients aged equal or more than 10 years old
- with keloids diagnosed clinically
- with any size less than 10 cm2
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Assiut University
Asyut
Doaa Samir, professor, 01143387171, doaasamir1@yahoo.com
Eman Fathy, lecturer, 01002258614, emanfathey639@yahoo.com
About this study
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 .
Read the 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.
- Conditions
- Keloid
- Being tested
- Insulin group, Botulinum toxin group, Triamcinolone acetonide group
- Medical subject headings
- Keloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin groupDrug
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 groupDrug
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.
Triamcinolone acetonide groupDrug
Also called control 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Triamcinolone acetonide group |
What is being measured
The primary outcome is the main question the study is designed to answer.
measure the changes of the level of IGFR1 in keloid before and after different lines of treatment
immunohistochemical stain
Measured: after 6 months of treatment
Secondary outcomes (1)
measure the changes in size and pliability of keloids after different lines of treatment
Vancouver scar scale
Measured: after 6 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start1 May 2024 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for KeloidStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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 .
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YSAbdelraheem, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06230146
- Sponsor's protocol ID
- ASUH
- Status last verified
- Jan 2024
- First submitted
- 22 Dec 2023
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 28287424Ohtsuru 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.
PubMed 10890181Betarbet 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.
PubMed 32308783Walsh 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.
PubMed 36918908Thornton 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.
PubMed 33542883Gassner 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.
PubMed 10839391Wang 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.
PubMed 32214835Zhang 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.
PubMed 26893621
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06230146
- Acronym / sponsor ID
- ASUH
- Conditions
- Keloid
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 30 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- 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 .
| Arm | Type | Receives |
|---|---|---|
| Insulin group | Experimental | Drug: Insulin groupGroup 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 | Experimental | Drug: Botulinum toxin groupGroup 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. |
| Triamcinolone acetonide group (control group) | Experimental | Drug: Triamcinolone acetonide groupGroup 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. |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged equal or more than 10 years old
- with keloids diagnosed clinically
- with any size less than 10 cm2
Key exclusion criteria (8 listed)
- Pregnancy
- Hypertrophic scars
- Diabetes mellitus
- Kidney or liver disease
- Active infection at site of lesion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insulin groupFractional 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 groupFractional 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 groupAlso: control groupFractional 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 (control group) |
Primary outcome
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
1 secondary outcome
measure the changes in size and pliability of keloids after different lines of treatment
Time frame: after 6 months of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- Background: PubMed 28287424Ogawa 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.
- Background: PubMed 10890181Ohtsuru 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.
- Background: PubMed 32308783Betarbet 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.
- Background: PubMed 36918908Walsh 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.
- Background: PubMed 33542883Thornton 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.
- Background: PubMed 10839391Gassner 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.
- Background: PubMed 32214835Wang 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.
- Background: PubMed 26893621Zhang 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Insulin group, Botulinum toxin group and Triamcinolone acetonide group in people with Keloid, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Doaa Samir, Professor (01143387171, doaasamir1@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measure the changes of the level of IGFR1 in keloid before and after different lines of treatment (time frame: after 6 months of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06230146, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2024.