Table 1.
All papers retrieved relating to CHC use in the management of fibrotic disorders, in their chronological order of publication
| Authors/refs | Disorder | Aim/end point | Key findings |
|---|---|---|---|
| Gelbard11 | PD | Effect of CHC on: healthy vs PD-affected tunica albuginea surrounding tissues following injection into rat femoral canal | No significant difference in the degree of collagen degradation between the diseased and healthy tissues Visible tissue clearing within the injection zone but not outside the radius of the zone Collagenolysis with preservation of elastin and no evidence of injury to local neurovasculature Macroscopic hematoma; microscopic venule and perineurium degradation with sparing of arterioles and endoneurium |
| Starkweather12 | DD | Effect of injected CHC on tensile strength of DD cords | Phase I: 3,600 U injection; 10 CHC vs 10 control injections; 93% decrease in tensile modulus Phase II: dose response (150/300/600 U/control); curvilinear trend between increased dose and decreased tensile strength |
| Badalamente13 | DD | In vivo effect of CHC on joint contractures – correction to ≤5° extension | Phase I: dose trial (300, 600, 1,200, 4,800, 9,600 U) – no cord rupture Phase II: 10,000 U; 29 patients – 88% correction of MCPJ, 44% full correction of PIPJ; 2 MCPJ, 2 PIPJ no response – surgery required; No major adverse reactions, no clinical systemic immune response |
| Badalamente14 | DD | In vivo effect of CHC on joint contractures – correction to ≤5° extension (PCRT) | Phase I: MCPJ – 14/18 CHC-injected joints achieved primary end point vs 2/18 placebo; 4/18 recurrence at 4 y PIPJ – 5/7 CHC-injected joints achieved primary end point vs 0/7 placebo; 4/7 recurrence at 4 y Phase II: dose-response (2,500, 5,000, 10,000, placebo): significantly dose related, 10,000 U most effective; 90% MCPJ and 70% PIPJ achieved primary end point; 1 MCPJ and 1 PIPJ of 80 patients showed recurrence at 2 y Substudy 1: pharmacokinetics of CHC – no CHC in serum; 28% of administered CHC dose found in urine 1 h after CHC injection in DD cord Substudy 2: addition of lidocaine for joint manipulation in 5 patients; well tolerated and no effect on end point |
| Kang16 | Keloid | Effects of CHC/triamcinolone/ combination of both on scar | Mixed keloid and hypertrophic scars (7 patients): keloid – 33% reduction in scar volume in first 6 mo, then effect lost; hypertrophic scars – no effect Patient-perceived severe reactions to treatment |
| Badalamente9 | DD | In vivo effect of CHC on joint contractures – correction to ≤5° extension (PCRT) | Blinded PCRT: 55 joints; 10,000 U/injection; multiple injections to achieve primary end point; 91% CHC joints achieved primary end point vs 0% placebo Open phase: 35 joints, given CHC injection; 77% achieved primary end point; 5/35 showed disease recurrence at 2 y |
| Del Carlo17 | PD and DD | In vitro effect of CHC when injected into PD plaques and DD cords | Enzymatic effect maximal at 4 h; near-complete digestion at 12 h; no cellular death; noncollagenous tissues unaffected |
| Hurst5 | DD | In vivo effect of CHC on joint contractures – correction to ≤5° extension (PCRT) | 512 joints: 64% CHC joints achieved primary end point vs 6.8% placebo joints 96.6% CHC joints developed ≥1 treatment-related adverse event vs 21.2% placebo joints 3 patients with severe CHC-related adverse events: 1 complex regional pain syndrome; 2 tendon ruptures Biochemical immune response in ≥85.8% of patients with 1 CHC injection and 100% with 3 CHC injections; no clinically apparent systemic immune responses |
| Watt3 | DD | Recurrence rate 8 y after single CHC injection – correction to ≤5° extension | MCPJ – 2/6 no recurrence; 4/6 recurrence PIPJ – 2/2 recurrence Patient perceived subjective success of treatment – 60% successful; 7/8 would consider repeat treatment |
Abbreviations: CHC, Clostridium histolyticum collagenase; PD, Peyronie disease; DD, Dupuytren disease; MCPJ, metacarpophalangeal joint; PIPJ, proximal interphalangeal joint; PCRT, placebo-controlled, randomized trial.