Lupton 2002.
Study characteristics | ||
Methods |
Study design: randomised trial Method of randomisation: not mentioned Blinding: participants ‐ no, doctor ‐ no, outcome assessors ‐ yes Power calculation: not mentioned Total number of participants: 20 Total number of procedures: 40 Treatment localisation: lower extremities Number of exclusions post‐randomisation: none Number of withdrawals and reasons: none |
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Participants |
Setting: outpatient site Country: USA Gender: women Age: range 27 – 68 years (mean 45 years) Inclusion criteria: skin photo types I – III, with size‐matched superficial leg telangiectases (diameter range 0.1 – 1.5 mm; mean 0.5 mm) Exclusion criteria: prior history of lower extremity telangiectasia treatment, clinical evidence of severe vascular incompetence, on anticoagulant treatment, or those currently pregnant or breastfeeding |
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Interventions |
Treatment 1: 2 treatments with a long‐pulsed 1064 nm Nd:YAG laser (Varia, Cool Touch Laser Corp., Auburn, LA) Treatment 2: 0.25% STS (Sotradecol, Elkins‐Sinn Inc., Cherry Hill, NJ) sclerotherapy Participants were randomised to receive 2 treatments with a long‐pulsed 1064 nm Nd:YAG laser to telangiectases on 1 leg and 0.25% STS sclerotherapy to those on the other. Size‐matched vessels on the thighs, knees, calves, ankles, and popliteal fossae received treatment by a single operator. Laser treatments were delivered through a 5.5 mm collimated spot size at 1 Hz using fluences of 125 – 150 J/cm2 (mean 135 J/cm2). A pulse duration of 25 msec was used for smaller vessels and a 50 msec pulse width was applied for vessels larger than 0.5 mm in diameter. Epidermal cooling was achieved with a cryogen spray of varying pre‐ and post‐treatment durations depending upon the skin photo type of the participant (i.e. longer pre‐cooling with darker skin photo types) and the size of the vessel (i.e. increased post‐cooling delay for larger vessels in order to effect full‐thickness mural denaturation). Precooling durations ranged from 0 to 5 msec, post‐cooling durations ranged from 20 to 50 msec, and post‐cooling delays ranged from 5 to 20 msec Duration of follow‐up: 1 ‐ 3 months Use of compression: compression stocking |
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Outcomes | Photographic documentation and clinical improvement scores were determined 1 month after the first treatment session, and 1 and 3 months after the second treatment session by 2 masked independent assessors using a quartile grading scale of 0: less than 25% improvement, 1: 26% – 50% improvement, 2: 51% – 75% improvement, and 3: greater than 75% improvement Side effects of treatment were also recorded at each treatment and follow‐up visit |
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Funding sources | Quote "No significant interest with commercial supporters" | |
Declarations of interest | None declared | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "Participants were randomised to receive two treatments with a long‐pulsed 1064 nm Nd:YAG laser" Comment: states "randomised", no further details given |
Allocation concealment (selection bias) | Unclear risk | No details given |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not possible to blind participants and personnel |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Photographic documentation and clinical improvement scores were determined 1 month after the first treatment session, and 1 and 3 months after the second treatment session by 2 masked independent assessors using a quartile grading scale of 0: less than 25% improvement, 1: 26% – 50% improvement, 2: 51% – 75% improvement, and 3: greater than 75% improvement. Side effects of treatment were also recorded at each treatment and follow‐up visit |
Incomplete outcome data (attrition bias) All outcomes | Low risk | There were no incomplete data |
Selective reporting (reporting bias) | Unclear risk | No details given |
Other bias | Unclear risk | No details given |