Intralesional Metformin Versus Triamcinolone for Keloid Treatment
NCT07922616, Phase 2, Completed, Al-Azhar University
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Intralesional Metformin Versus Triamcinolone for Keloid Treatment | ClinicalTrials.gov |
| NCT number | NCT07922616 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Phase 2 | ClinicalTrials.gov |
| Enrollment | 30 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Al-Azhar University | ClinicalTrials.gov |
| Conditions | Keloids | ClinicalTrials.gov |
| Interventions | Intralesional Metformin, Intralesional Triamcinolone Acetonide | ClinicalTrials.gov |
| First posted | 2026-11-06 | ClinicalTrials.gov |
| Last updated | 2026-11-06 | ClinicalTrials.gov |
Registered outcomes 5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change from baseline in the Vancouver Scar Scale (VSS) Score at Week 19 | Baseline and Week 19 (one month after the 6th treatment session) | • The Vancouver Scar Scale (VSS) evaluated scar vascularity (0 = normal, 1 = pink, 2 = red, 3 = purple), pigmentation (0 = normal, 1 = hypopigmentation, 2 = mixed, 3 = hyperpigmentation), pliability (0 = normal, 1 = supple, 2 = yielding, 3 = firm, 4 = ropes, 5 = contracture), and height (0 = flat, 1 = \<2mm, 2 = 2-5mm, 3 = \>5mm). Total scores ranged from 0 to 14, with 0 indicating normal skin and 14 indicating the most severe scarring. The reduction in the total VSS score was used to categorize treatment response into four clinical categories: poor (1-25% reduction), fair (26-50% reduction), good (51-75% reduction), or excellent (\>75% reduction). Changes were compared between metformin-treated and triamcinolone-treated lesions. Assessments were supported by standardized digital photographs obtained using Identical camera settings, lighting conditions, and patient positioning. Changes were compared between metformin-treated and triamcinolone-treated lesions. | ClinicalTrials.gov |
| Primary | Change From Baseline in Keloid Thickness and Length Assessed by Ultrasonography at Week 19 | Baseline and Week 19 (one month after the 6th treatment session) | Objective treatment efficacy was assessed by high-resolution ultrasonography using a Philips Affiniti 70 ultrasound system (Philips, Amsterdam, Netherlands) equipped with a 10-MHz linear-array transducer. The ultrasonographic parameters evaluated were keloid thickness and length, both measured in millimeters. The change was calculated by subtracting the baseline score from the final clinical score obtained at the assessment visit 1 month after the last (6th) treatment session. Changes were compared between metformin-treated and triamcinolone-treated lesions. | ClinicalTrials.gov |
| Secondary | Patient Satisfaction Score at Week 19 | Week 19 (one month after the 6th treatment session) | Patient satisfaction was evaluated using a 5-point scale ranging from 0 to 4. On this scale, a score of 0 indicates "not satisfied"; 1 = mild satisfaction; 2 = moderate satisfaction; 3 = good satisfaction; and 4 = excellent satisfaction (which correlated with more than 75% perceived clinical improvement). | ClinicalTrials.gov |
| Secondary | Number of Participants with Treatment-Related Adverse Events through Week 27 | Baseline up to Week 27 (three months after the 6th treatment session). | Safety and tolerability were evaluated by documenting the total number of participants who developed side effects after injection into the treated keloid lesions. Monitoring was performed by the investigator at each injection session (weeks 0, 3, 6, 9, 12, and 15) and monthly for 3 months post-treatment. Specific adverse events monitored included pain, swelling, infection, pigmentary changes, ulceration, and skin atrophy. A participant was counted if they experienced one or more of these events at any point during the evaluation period. | ClinicalTrials.gov |
| Secondary | Number of Participants Experiencing Recurrence From Week 15 up to Week 27 | From Week 15 up to Week 27 (three months after the 6th treatment session). | Keloid recurrence was evaluated through clinical examination to detect the reappearance of active keloid tissue growth. Lesions that achieved complete clinical healing or flattening at the end of the treatment sessions were monitored longitudinally. Recurrence is defined as an increase in volume, height, or vertical regrowth of the scar tissue. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 14
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 25777304 | BACKGROUND | PubMed |
| 26758090 | BACKGROUND | PubMed |
| 26894654 | BACKGROUND | PubMed |
| 29993130 | BACKGROUND | PubMed |
| 30087573 | BACKGROUND | PubMed |
| 30775139 | BACKGROUND | PubMed |
| 31240510 | BACKGROUND | PubMed |
| 31341409 | BACKGROUND | PubMed |
| 32109921 | BACKGROUND | PubMed |
| 34007848 | BACKGROUND | PubMed |
| 34526861 | BACKGROUND | PubMed |
| 36918908 | BACKGROUND | PubMed |
| 37236718 | BACKGROUND | PubMed |
| 39331598 | BACKGROUND | PubMed |
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)