Intralesional injection therapy for hypertrophic scars and keloids

Overview

Intralesional injection therapy is the workhorse of nonsurgical management for hypertrophic scars and keloids after burns. Keloids and hypertrophic scars are fibroproliferative disorders with high recurrence rates that lack a definitive treatment standard ^[2]. Intralesional injection is one of the most commonly used treatment modalities for these lesions because it is simple, nontraumatic, and delivered in the clinic ^[33]. The agents most commonly studied are triamcinolone acetonide (TAC), 5-fluorouracil (5-FU), botulinum toxin A (BTA), verapamil, and bleomycin ^[33].

Across the synthesis literature, intralesional steroid injection is identified as the first-line therapy for keloids and hypertrophic scars ^[21], and corticosteroid plus excision remain critical benchmarks for evaluating new treatments ^[2]. The mainstay of clinically proven scar therapy is multimodal, glucocorticoid-centered regimens that show consistent therapeutic outcomes ^[4]. Practice has shifted toward combinations; silicone with corticosteroid injections sits at the top of first-line algorithms, with adjuvant 5-fluorouracil, bleomycin, or verapamil considered for selected lesions ^[31]. The narrative below organizes that evidence by agent, then by surgical-adjuvant role, complications, and special populations.

Burn-relevance and evidence scope

The burn-specific intralesional-injection literature is thin. A systematic review of randomized controlled trials in hypertrophic burn scar management identified only 882 patients across 20 trials, with the intralesional-therapy slice contributing 18 patients in a single article ^[1]. The authors concluded that despite hypertrophic scars being a common occurrence in burn survivors, both the number of studies and consensus for treatment are limited ^[1]. A larger but still small body of pediatric burn-scar evidence supports laser-assisted topical triamcinolone delivery via fractional CO2 laser plus immediately applied triamcinolone suspension and post-session topical clobetasol propionate ^[24] and non-ablative fractional laser plus intralesional triamcinolone ^[25] in postburn hypertrophic scars in children, and a 2025 randomized trial of 150 burn patients showed 5-FU combined with ultra-pulsed fractional CO2 laser outperformed laser alone ^[23].

The broader evidence base for intralesional pharmacotherapy is dominated by dermatology and plastic-surgery keloid trials. The current page extrapolates from that dermatology-keloid literature to inform burn-scar practice; this extrapolation policy was set at Stage 3.5 of the evidence pipeline. Where burn-specific data exist, the page identifies them by name. Where the evidence comes from dermatology-keloid trials, the page cites the dermatology source.

Pathophysiology and rationale by agent

The agents used intralesionally act on different points of the fibroproliferative cascade. Corticosteroids and 5-fluorouracil target fibroblast proliferation and collagen synthesis; calcium channel blockers act on extracellular matrix turnover; botulinum toxin A modulates mechanical tension and TGF-β signaling.

Triamcinolone acetonide remains the best and safest treatment for keloid management based on current data ^[4]. 5-fluorouracil is an antimetabolite that inhibits fibroblast proliferation and collagen synthesis ^[42]. Verapamil, a calcium channel blocker, has been postulated to trigger extracellular matrix degradation in dermal scars and to reduce scar volume ^[38]; calcium antagonists have been found to reduce extracellular matrix production, induce procollagenase synthesis, and inhibit interleukin-6, vascular endothelial growth factor, and proliferation of fibroblasts ^[14]. Botulinum toxin type A prevents fibroblast proliferation and expression of transforming growth factor beta 1 ^[20]; animal-model evidence further suggests TAC plus BTX-A combination therapy enhances scar reduction by more effectively suppressing fibroblast proliferation and activation through TGF-β and CTGF downregulation ^[20].

Triamcinolone acetonide

Triamcinolone acetonide is the most consistently studied intralesional agent for hypertrophic scars and keloids ^[6]. A systematic review and meta-analysis of fifteen trials found that TAC in the short term significantly improved vascularity and pliability compared with verapamil ^[6]. The same review concluded that TAC may be beneficial for short-term treatment of hypertrophic scars and keloids, while 5-FU, 5-FU+TAC, and verapamil may produce superior results for medium- and long-term treatments ^[6]. A more recent systematic review of glucocorticoid-based therapies concluded that the best and safest treatment for keloid management is intralesional TAC based upon the data at hand ^[4]. In a 2025 systematic review of therapeutic interventions for hypertrophic and keloid scarring, triamcinolone produced the greatest scar reduction (82.2 percent), followed by Nd:YAG laser (65.44 percent) and verapamil (57.7 percent) ^[5].

TAC concentrations of 20 mg/mL and 40 mg/mL are the doses most directly characterized in the comparative safety literature, where these concentrations were more likely to cause skin atrophy than 5-FU or verapamil and more likely to cause telangiectasia than 5-FU, 5-FU+TAC, or bleomycin ^[6]. The procedure is painful; topical anesthetic application before injection significantly relieves needle-stick pain, especially at sternum and auricular keloids, although a lidocaine mixture does not alleviate pain during the injection itself ^[36].

Combination triamcinolone and 5-fluorouracil

Combination intralesional triamcinolone with 5-fluorouracil consistently outperforms either agent alone for keloid and hypertrophic-scar management. A 2024 systematic review and meta-analysis of thirteen studies (twelve RCTs plus one nonrandomized comparison) found that the combined group demonstrated superior objective treatment efficacy compared with monotherapy TAC (OR 3.45; 95% CI 2.22 to 5.35) and monotherapy 5-FU (OR 4.17; 95% CI 2.21 to 7.87) ^[7]. Telangiectasia was less frequent in combination therapy compared with monotherapy TAC (OR 0.24; 95% CI 0.11 to 0.52) ^[7]. A separate 2024 systematic review and meta-analysis of fifteen studies found that the corticosteroid plus 5-FU group performed better than control for scar height (WMD −0.38; 95% CI −0.58 to −0.18) and had less hypopigmentation, skin atrophy, and telangiectasia than control ^[8]. The 2021 TAC systematic review reached the same direction at the longer-term horizon: compared with TAC alone, TAC+5-FU produced significant improvement in scar height (MD 1.50; 95% CI 1.12 to 1.88), pliability (MD 0.45; 95% CI 0.10 to 0.80), and pigmentation (MD 0.55; 95% CI 0.24 to 0.86) ^[6].

A 2024 systematic review of intralesional 5-FU monotherapy for keloids (forty studies, 2325 patients) reported that 5-FU monotherapy produced ≥25 percent improvement in 73 percent of patients and ≥50 percent improvement in 67 percent, with a 16 percent relapse rate at 27 weeks ^[9]. Across syntheses, 5-FU is most often compared with intralesional triamcinolone using the Patient and Observer Scar Assessment Scale and the Vancouver Scar Scale ^[9].

Verapamil

Intralesional verapamil is an alternative to triamcinolone with a clearly different efficacy-versus-toxicity profile. Multiple systematic reviews converge on the finding that TAC works faster while verapamil is safer [10, 11]. A 2020 systematic review and meta-analysis concluded that TAC improved scar pliability and vascularity more than verapamil after three weeks, but verapamil resulted in fewer cases of skin atrophy ^[10]. A second 2020 SR/MA found no significant differences between verapamil and TAC in reduction of height or vascularity at later time points, with significantly lower telangiectasia and skin atrophy in the verapamil arm; the authors suggested verapamil might be used as an alternative when TAC results in adverse outcomes ^[11]. A 2023 systematic review and meta-analysis added that verapamil group showed a significantly lower incidence of skin atrophy, telangiectasia, and hypopigmentation compared with TAC, with higher burning sensation during injection ^[12]. A 2021 meta-analysis reached the same conclusion: total adverse effects did not change between groups, but telangiectasia and skin atrophy were significantly lower with verapamil than with TAC ^[13].

The mechanism rationale and historical sequence is documented. Calcium antagonists reduce extracellular matrix production, induce procollagenase synthesis, and inhibit interleukin-6, VEGF, and fibroblast proliferation ^[14]; the first clinical report of control of burn scar with calcium channel blockers used intralesional verapamil hydrochloride at 0.1 to 0.5 mmol/L in five patients with hypertrophic burn scarring ^[38]. A 2016 trial in twenty patients with postburn keloids reported that verapamil was useful in conjunction with pressure garment to improve keloid and hypertrophic-scar conditions caused by burn ^[39].

Bleomycin

Intralesional bleomycin has emerged as an effective option with a distinct adverse-event profile. A 2025 real-world systematic review and meta-analysis of eight retrospective studies covering 562 patients reported that 90 percent of patients had significant flattening of scars after bleomycin treatment, with a 3 percent recurrence rate; the major adverse reaction was hyperpigmentation (8 percent), with no significant ulcers or skin atrophy ^[15]. A 2024 systematic review and meta-analysis found bleomycin caused less skin atrophy and telangiectasia but more pain than other treatments, and was more effective than TAC, 5-FU, or TAC+5-FU for treating keloids and hypertrophic scars with lower skin atrophy and telangiectasia risks ^[17]. A 2020 SR/MA confirmed bleomycin's efficacy across keloid and hypertrophic scar populations ^[16].

Racial-difference effects on outcomes are documented: in the real-world meta-analysis, significant flattening was 99 percent in Western patients and 57 percent in Asian patients ^[15], underscoring the importance of population context when generalizing efficacy.

Botulinum toxin A

Botulinum toxin A has accumulated meta-analytic evidence as both a primary intralesional agent and a combination partner with TAC. A 2024 meta-analysis of seven articles (237 patients) concluded that botulinum toxin has a positive effect on preventing hyperplastic scars in the maxillofacial and neck areas, and can also help fade existing scars ^[18]. The 2021 TAC SR/MA found that BTX-A resulted in significantly better pliability (SMD 1.99; 95% CI 0.98 to 3.00) compared with TAC alone ^[6]. A 2024 meta-analysis of eleven studies (561 patients) found BTA combined with TCA demonstrated higher effective rate (RR 1.28; 95% CI 1.14 to 1.44), better VAS scores (WMD −1.69), and better Vancouver Scar Scale scores (WMD −1.46) versus control, although the influence on scar thickness was limited (WMD −0.11; not significant) ^[19]. A 2025 translational pilot study in adult patients with hypertrophic scars and keloids, using a split-scar design with paired rat-burn-scar histological work, reported that the TAC+BTX-A combination showed superior reductions in scar thickness and VSS scores compared with BTX-A monotherapy, with the proposed mechanism being more effective suppression of fibroblast proliferation through TGF-β and CTGF downregulation ^[20]. Pain (NRS) and pruritus (VAS) scores did not differ between the combination and monotherapy arms ^[20].

A 2026 network meta-analysis suggested that data for novel agents (including BTX-A) are promising but underrepresented in comparative analyses, and that further research with standardized methodologies and longer-term follow-up is needed to define optimal treatment algorithms ^[3].

Cryotherapy and laser-assisted drug delivery as adjuncts

Two device-based adjuncts repeatedly appear alongside intralesional pharmacotherapy. Cryotherapy combined with intralesional steroid injection was evaluated in a 2026 systematic review and meta-analysis of thirteen studies (1012 cases), which found that the combination yielded a significantly higher efficacy rate than various control interventions including intralesional steroid monotherapy, cryotherapy alone, bleomycin or verapamil treatment, laser plus steroid, and surgical excision plus radiotherapy (RR 1.19; 95% CI 1.03 to 1.36) ^[21]. However, the same meta-analysis detected no statistically significant difference in mean percentage change in scar improvement (SMD 0.14; 95% CI −0.39 to 0.68) or in overall adverse-event incidence (RR 1.35; 95% CI 0.99 to 1.83) versus controls ^[21]. The authors framed cryotherapy plus intralesional steroid as a potential alternative to other first-line treatments for keloids and hypertrophic scars while cautioning that clinical recommendations should be made based on specific patient and scar conditions ^[21].

Laser-assisted drug delivery (LADD) uses fractional ablative lasers to create microchannels that allow drug penetration into the scar. A 2024 systematic review concluded that LADD is a more effective treatment modality than topical application of agents in hypertrophic scars and equally effective as intralesional injection in keloids, with few reported adverse events ^[22]. The reviewers framed LADD as an adjunct to non-surgical measures or as a treatment to use before more invasive measures such as surgical excision, while noting that the quality of evidence supporting this conclusion is inconsistent and lacks power ^[22]. In burn-specific data, a 2025 randomized controlled trial of 150 patients with hypertrophic scars from burns reported that 5-FU combined with ultra-pulsed fractional CO2 laser was significantly more effective than laser treatment alone, with risk factors for poorer response including advanced age, longer disease duration, and higher pre-treatment Vancouver Scar Scale scores ^[23]. A 2018 pediatric series of ten children with postburn hypertrophic scars treated with fractional CO2 laser plus immediate topical triamcinolone reported mean VSS reduction of 4.2 points (range 2.8 to 7) ^[24], and a 2025 trial combining non-ablative fractional laser with intralesional triamcinolone in children with postburn hypertrophic scars showed the combination group reached a median post-treatment modified VSS of 5 versus 7 (laser alone) versus 9 (triamcinolone alone) ^[25]. Adding 595-nm pulsed-dye laser to IL TAC for postmastectomy hypertrophic scars and keloids in transgender men produced significantly greater VSS and melanin-index improvements than IL TAC alone ^[41].

Adverse events and pitfalls

The adverse-event profile of intralesional therapy is dominated by local skin changes and, at higher steroid concentrations or in children, systemic steroid effects. TAC injections at concentrations of 20 mg/mL or 40 mg/mL are more likely to result in skin atrophy compared with 5-FU or verapamil, and are more likely to cause telangiectasia than 5-FU, 5-FU+TAC, or bleomycin ^[6]. A 2006 split-scar trial of TAC alone versus combinations reported atrophy and telangiectasia in 37 percent of patients treated with corticosteroid intralesionally alone ^[40]. The corticosteroid plus 5-FU SR/MA found that the combination had less hypopigmentation, skin atrophy, and telangiectasia than control ^[8].

Cushing's syndrome is a documented systemic complication. A 2013 systematic review of the world literature identified 18 reported cases of Cushing's syndrome after intralesional TAC, with a multinational survey revealing that at least 30 percent of plastic surgeons exceed the recommended dosage and 47 percent are not aware of Cushing's syndrome as a possible complication ^[26]. The same review concluded that published literature suggests TAC administered within the most recent recommendations does not appear to place adult patients at increased risk; the review recommends that intralesional dosage not exceed 30 mg per month in children, noting that at least one reported case of Cushing's syndrome resulted from a smaller dose ^[26].

Pain during the injection itself is a consistent limitation. Topical anesthetic application significantly relieves needle-stick pain, especially at sternum and auricular keloids, but a lidocaine mixture does not alleviate pain during injection ^[36]. Needle-free jet-injector-assisted intralesional treatments (including triamcinolone, 5-FU, and bleomycin) show favorable efficacy and safety outcomes, with limited evidence suggesting jet injection is efficacious and safe for hypertrophic and atrophic scars ^[37].

Surgical adjuvant role

Intralesional therapy is also used to lower recurrence after surgical excision of keloids. A 2024 systematic review and meta-analysis aimed to identify the optimum time for triamcinolone injection of keloids, comparing recurrence and complications by pre-, intra-, and post-operative injection timing ^[28]. A 2016 SR comparing triamcinolone with radiation therapy after surgical excision of ear keloids reported recurrence rates of 15.4 percent (95% CI 9.4 to 24.1) for triamcinolone versus 14.0 percent (95% CI 9.6 to 19.9) for radiation therapy ^[29]. A 2020 SR/MA of surgical excision plus adjuvant multimodal therapies found that the difference in recurrence rates between dual therapy (19 percent) and triple therapy (11.2 percent) was not significant overall; however, the difference between dual therapy using surgery and radiation (18.7 percent) and triple therapy using surgery, radiation, and a third intervention (7.7 percent) was significant ^[30]. Triple therapy with surgery, radiation, and TAC was identified as achieving the lowest recurrence rates for keloids ^[30].

The 2023 evidence-based systematic review of keloid treatments concluded that current literature supports silicone gel or sheeting with corticosteroid injections as first-line therapy for keloids; adjuvant intralesional 5-FU, bleomycin, or verapamil can be considered, although mixed results have been reported with each; laser therapy can be used in combination with intralesional corticosteroids; and excision with immediate post-excision radiation therapy is effective for recalcitrant lesions ^[31].

Comparative ranking and network meta-analyses

Network meta-analyses now provide structured rankings. A 2024 network meta-analysis of twenty randomized controlled trials (1114 patients) found that botulinum toxin A alone and TAC plus 5-FU exhibited significantly better efficacy than did 5-FU, TAC, and verapamil; no significant difference in efficacy between BTA alone and TAC combined with 5-FU was observed; no significant differences were noted in adverse event rate between BTA, TAC plus 5-FU, 5-FU, and TAC ^[33]. The predicted ranking by efficacy was TAC+5-FU, BTA, bleomycin, TAC, 5-FU, verapamil; the predicted ranking by adverse events was TAC, 5-FU, TAC+5-FU, and BTA ^[33]. A 2026 network meta-analysis of intralesional therapies for keloid scars (51 studies, 3234 participants, 23 interventions) concluded that combination therapies (most notably 5-FU + corticoids + YAG laser) offer the greatest benefit; 5-FU + corticoids significantly improved keloid reduction compared with corticoids alone (RR 1.59; 95% CI 1.31 to 1.92) ^[3]. The 2022 management of HTS in adults SR/MA found that silicone and laser modalities improved VSS scores by 5.06 and 3.56 points respectively, and that intralesional triamcinolone combined with silicone or 5-FU was superior to intralesional triamcinolone monotherapy ^[34].

A 2017 systematic review of invasive and noninvasive treatment modalities for hypertrophic scars identified intralesional injections of 5-FU mixed with a low dose of TAC as the most appropriate treatment modality among the six high-level-of-evidence trials reviewed ^[32]; intralesional injections in that review revealed significant improvements in scar quality in terms of height, thickness, erythema, and pigmentation ^[32]. The 2024 corticosteroid plus 5-FU SR/MA noted that the combination of corticosteroids and 5-FU appears to be a more effective strategy for the treatment and prevention of hypertrophic scars and keloids, with greater improvements in scar height and overall effectiveness coupled with a reduced incidence of side effects ^[8].

Pediatric considerations

Pediatric burn-scar treatment with intralesional therapy carries specific safety constraints. The 2013 Cushing's-after-TAC systematic review identified children as most at risk and recommends a 30 mg per month ceiling for intralesional dosage; at least one reported case resulted from a smaller dose ^[26]. A 1996 case series reported two pediatric cases of Cushing's syndrome following treatment of hypertrophic burn scars with intralesional triamcinolone acetonide; in both, therapy was initiated 3 months post-burn and the maximum recommended dose was not exceeded; Cushing's manifestations developed 1 to 2 weeks post-injection and resolved in 6 to 8 weeks with no permanent sequelae ^[27]. The authors concluded that intralesional triamcinolone acetonide should be used with an increased degree of caution in the pediatric population ^[27].

Efficacy data in children support combination protocols, though some protocols use laser-assisted topical delivery rather than classical intralesional injection. A 2018 series of ten children (ages 5 to 12 years) with postburn hypertrophic scars treated with three to five sessions of fractional CO2 laser resurfacing at one-month intervals plus immediately applied triamcinolone suspension and post-session topical clobetasol propionate gel for one week reported mean VSS reduction of 4.2 points (range 2.8 to 7), with ≥4-point reduction in eight of ten cases ^[24]. A 2025 trial in children with postburn hypertrophic scars found that combining non-ablative fractional laser therapy with intralesional triamcinolone injections is effective and safe, with the combination group reaching a significantly lower median post-treatment modified VSS score than laser-only or triamcinolone-only groups (5 versus 7 versus 9) ^[25].

Special considerations in darker Fitzpatrick skin types

A 2025 systematic review of treatment efficacy in individuals with darker Fitzpatrick skin types reported that combining silicone gel sheeting, intralesional corticosteroids, laser therapy, and pressure therapy was generally more effective for hypertrophic scars ^[35]. Surgical excision followed by brachytherapy showed recurrence rates of about 3.1 percent for keloids in this population ^[35]. The reviewers noted that darker Fitzpatrick skin types were underrepresented in existing scar severity scales, pointing to a gap in tailored outcome measures, and that potential side effects like hyperpigmentation must be considered ^[35].

Outcomes

Outcomes across the intralesional-therapy literature are most commonly assessed with the Vancouver Scar Scale (VSS), the Patient and Observer Scar Assessment Scale (POSAS), and lesion-specific parameters of height, pliability, vascularity, and pigmentation [9, 23]. Improvement signals are agent-specific: short-term TAC drives vascularity and pliability gains ^[6]; medium- and long-term TAC+5-FU drives height, pliability, and pigmentation gains ^[6]; bleomycin produces significant flattening in 90 percent of patients in real-world data ^[15]; BTX-A combinations with TAC reach RR 1.28 for effective rate and improve VAS and VSS scores meaningfully ^[19]. Recurrence rates after combined surgery-plus-intralesional regimens range from 7.7 to 19 percent across keloid series, reaching their lowest values with triple therapy that adds radiation and intralesional steroid to excision (7.7 percent versus 18.7 percent for surgery plus radiation alone) ^[30].

Controversies and Evidence Gaps

Several questions are unresolved. First, no agent has emerged as a definitive standard. The 2026 systematic review of therapeutic methods notes that keloids and hypertrophic scars lack a definitive treatment standard, and that despite the lack of an established gold standard, corticosteroid and excision therapies remain critical benchmarks ^[2]. Second, burn-specific data are sparse; the burn-specific RCT base for intralesional therapy includes only 18 patients in one trial, and most evidence is extrapolated from dermatology-keloid populations ^[1]. Third, optimal dosing intervals and concentrations are not standardized; comparative meta-analyses of TAC have characterized 20 mg/mL and 40 mg/mL concentrations in terms of relative adverse-event risk versus 5-FU, verapamil, and bleomycin, but a single dominant dosing protocol has not been established ^[6]. Fourth, long-term durability data are limited; one bleomycin meta-analysis reported a 3 percent recurrence rate but follow-up was variable and the included studies were retrospective ^[15]. Fifth, comparative-effectiveness data for novel agents (botulinum toxin A and insulin among others) are still maturing; the 2026 network meta-analysis flags BTX-A as underrepresented in comparative analyses despite promising direction ^[3]. Sixth, racial and skin-type effects on outcome are documented but underrepresented in scar severity scales [15, 35]. Finally, periprocedural pain management remains a friction point that limits patient adherence to multi-session protocols ^[36].

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