A systematic review of outcome reporting in laser treatments for dermatological diseases.

The standardization of outcome reporting is crucial for interpretation and comparison of studies related to laser treatment of skin disorders. In collaboration with the Cochrane Skin-Core Outcome Set Initiative (CS-COUSIN), a procedure has been proposed to find consensus on the most important generic outcome domains (what to measure) for implementation in the international Laser TrEAtment in Dermatology (LEAD) registry. As the first step in the development of a generic outcome set for the LEAD registry, we undertook a systematic review to identify outcomes, outcome measurement instruments, methods and definitions reported in recently published literature of laser treatments for skin disorders. A systematic search was conducted and generated a total of 707 papers. We assessed 150 studies including all types of studies involving laser treatments for the skin. Two researchers independently extracted the type, definition and frequency of all outcomes and used outcome measurement instruments. We identified 105 verbatim outcomes that were categorized into eight domains recommended by the COMET framework: appearance, long-term effects, physician and patient-reported physical signs, satisfaction, health-related quality of life, psychological functioning and adverse events. Heterogeneity in outcome reporting (e.g. categories and outcome measurement instruments) was high, and definitions were insufficiently reported. There was a clear under representation of life impact domains, including satisfaction (23%) quality of life (3%) and psychological functioning (1%). Outcome reporting concerning laser treatments for the skin is heterogeneous. Standardized outcomes are needed for improving evidence synthesis. Results of this review will be used in the next step to reach consensus between stakeholders on the outcome domains to be implemented in the LEAD registry.

Propranolol in the treatment of infantile haemangiomas: lessons from the European Propranolol In the Treatment of Complicated Haemangiomas (PITCH) Taskforce survey.

BACKGROUND: Oral propranolol is widely prescribed as first-line treatment for infantile haemangiomas (IHs). Anecdotally, prescribing practice differs widely between centres. OBJECTIVES: The Propranolol In the Treatment of Complicated Haemangiomas (PITCH) Taskforce was founded to establish patterns of use of propranolol in IHs. METHODS: Participating centres entered data on all of their patients who had completed treatment with oral propranolol for IHs, using an online data capture tool. RESULTS: The study cohort comprised 1097 children from 39 centres in eight European countries. 76·1% were female and 92·8% had a focal IH, with the remainder showing a segmental, multifocal or indeterminate pattern. The main indications for treatment were periocular location (29·3%), risk of cosmetic disfigurement (21·1%) and ulceration and bleeding (20·6%). In total 69·2% of patients were titrated up to a maintenance regimen, which consisted of 2 mg kg(-1) per day (85·8%) in the majority of cases. 91·4% of patients had an excellent or good response to treatment. Rebound growth occurred in 14·1% upon stopping, of whom 53·9% were restarted and treatment response was recaptured in 91·6% of cases. While there was no significant difference in the treatment response, comparing a daily maintenance dose of < 2 mg kg(-1) vs. 2 mg kg(-1) vs. > 2 mg kg(-1) , the risk of adverse events was significantly higher: odds ratio (OR) 1 vs. adjusted OR 0·70, 95% confidence interval (CI) 0·33-1·50, P = 0·36 vs. OR 2·38, 95% CI 1·04-5·46, P = 0·04, Ptrend < 0·001. CONCLUSIONS: The PITCH survey summarizes the use of oral propranolol across 39 European centres, in a variety of IH phases, and could be used to inform treatment guidelines and the design of an interventional study.

Long-pulsed dye laser vs. intense pulsed light for the treatment of facial telangiectasias: a randomized controlled trial.

OBJECTIVE: This study aims to compare the efficacy and adverse effects of long-pulsed dye laser (LPDL) and intense pulsed light (IPL) in the treatment of facial telangiectasias. METHODS: We used intra-individual, randomized, controlled trial with split-face treatments and single-blind outcome evaluations in this study. Forty patients with symmetrically located facial telangiectasias received a series of three LPDL (V-beam, 595 nm, Candela Laser Corp.) and three IPL treatments (Ellipse Flex, PR and VL2 applicators, Danish Dermatologic Development) at 6-week intervals. Patients were evaluated 3 months after the final treatment. Outcome measures were clinical efficacy (five-point ordinal scale), pain (10-point numerical scale), adverse effects, patient satisfaction (10-point numerical scale) and preferred treatment. RESULTS: Thirty-nine of 40 patients completed the study. All but 2 patients obtained a reduction in facial telangiectasias from both IPL and LPDL treatments. Both treatments were effective with good or excellent response in 30 of 39 patients. The LPDL was superior in the overall reduction of telangiectasias by blinded photographic evaluations: Excellent clearance (75% to 100% vessel clearance) was found in 18 patients treated with LPDL (46%) and in 11 patients treated with IPL (28%) (P = 0.01). Patients experienced less pain from LPDL [4 (2-6)] than IPL treatments [7 (3-9)] (P < 0.001). No adverse effects (hypo-/hyperpigmentation or scarring) were seen from any of the treatments. Patients were satisfied with both LPDL [8 (2-10)] and IPL treatments [7 (2-10)] (P = 0.05). Twenty-five patients preferred the LPDL (64%), 8 patients preferred IPL (21%) and 6 patients had no preference (15%) (P < 0.001). CONCLUSION: This study was based on two specific types of laser and IPL equipment, which effectively clear telangiectasias; however, the most beneficial outcome was from the LPDL.

Intense pulsed light vs. long-pulsed dye laser treatment of telangiectasia after radiotherapy for breast cancer: a randomized split-lesion trial of two different treatments.

BACKGROUND: Chronic radiodermatitis is a common sequela of treatment for breast cancer and potentially a psychologically distressing factor for the affected women. OBJECTIVES: To evaluate the efficacy and adverse effects of treatments with a long-pulsed dye laser (LPDL) vs. intense pulsed light (IPL) in a randomized split-lesion trial. METHODS: Thirteen female volunteers with radiodermatitis and Fitzpatrick skin types II-III were included in the study. Subjects received a series of three treatments at 6-week intervals with half-lesion LPDL (V-beam Perfecta, 595 nm) and half-lesion IPL (Ellipse Flex); the interventions were randomly assigned to left/right or upper/lower halves. Primary end-points were reduction in telangiectasia, patient satisfaction and preferred treatment. Secondary end-points were pain and adverse effects. Efficacy was registered by blinded photographic evaluations 3 months after the final treatment. RESULTS: Eleven patients completed the study. Telangiectasia cleared with both treatments but the efficacy of LPDL was superior. Blinded photographic evaluations showed median vessel clearances of 90% (LPDL) and 50% (IPL) (P = 0.01). LPDL treatments were associated with lower pain scores than IPL treatments [median visual analogue scale (VAS) score 4.3 and 6.0, respectively, P < 0.01]. Patients were slightly more satisfied with LPDL (median VAS score 8) than IPL treatments (median VAS score 7; P < 0.05) and more preferred LPDL (n = 9) to IPL (n = 2) (P < 0.01). Two patients withdrew from the study because of hypopigmentation of the IPL treated areas, which slowly repigmented within 1 year. CONCLUSIONS: This study was based on two specific laser and IPL devices, and found the LPDL treatment to be advantageous compared with IPL due to superior vessel clearance and less pain.

Carcinogenesis related to intense pulsed light and UV exposure: an experimental animal study.

This study examines whether intense pulsed light (IPL) treatment has a carcinogenic potential itself or may influence ultraviolet (UV)-induced carcinogenesis. Secondly, it evaluates whether UV exposure may influence IPL-induced side effects. Hairless, lightly pigmented mice (n=144) received three IPL treatments at 2-week intervals. Simulated solar radiation was administered preoperatively [six standard erythema doses (SED) four times weekly for 11 weeks] as well as pre- and postoperatively (six SED four times weekly up to 26 weeks). Skin tumors were assessed weekly during a 12-month observation period. Side effects were evaluated clinically. No tumors appeared in untreated control mice or in just IPL-treated mice. Skin tumors developed in UV-exposed mice independently of IPL treatments. The time it took for 50% of the mice to first develop skin tumor ranged from 47 to 49 weeks in preoperative UV-exposed mice (p=0.94) and from 22 to 23 weeks in pre- and postoperative UV-exposed mice (p=0.11). IPL rejuvenation of lightly pigmented skin did not induce pigmentary changes (p=1.00). IPL rejuvenation of UV-pigmented skin resulted in an immediate increased skin pigmentation and a subsequent short-term reduced skin pigmentation (p<0.002). Postoperative UV radiation resulted in re-pigmentation of IPL-induced pigment reduction (p=0.12). No texture changes were observed. Postoperative edema and erythema were increased by preoperative UV exposure (p<0.002). IPL rejuvenation has no carcinogenic potential itself and does not influence UV-induced carcinogenesis. UV exposure influences the occurrence of side effects after IPL rejuvenation in an animal model.

Ablative versus non-ablative treatment of perioral rhytides. A randomized controlled trial with long-term blinded clinical evaluations and non-invasive measurements.

BACKGROUND AND OBJECTIVE: To compare efficacy and side effects of CO(2) laser resurfacing and intense pulsed light (IPL) rejuvenation for treatment of perioral rhytides. METHODS: Twenty-seven female subjects with perioral rhytides (class I-III) were randomly treated with either CO(2) laser or IPL (three monthly treatments). Efficacy was evaluated by patient self-assessments and blinded photographs up to 12 months postoperatively. Side effects were assessed clinically. Non-invasive measurements included: trans epidermal water loss (TEWL), skin reflectance, skin elasticity, and ultrasound. RESULTS: CO(2) laser resurfacing resulted in higher degrees of patient satisfaction and clinical rhytide reduction compared to IPL rejuvenation up to 12 months postoperatively (patient evaluations, P < 0.05) (observer evaluations, P < 0.008). Laser-induced side effects included erythema, dyspigmentation, and milia whereas no side effects were observed after IPL rejuvenation. Non-invasive measurements showed a significant higher reduction of the subepidermal low-echogenic band in CO(2) laser treated areas versus IPL treated areas (12 months postoperatively, P < 0.001). Skin elasticity (expressed as Young's modulus) increased in both groups (P = ns). One month postoperatively a significant increase in TEWL values (P < 0.009) and skin redness% (P < 0.02) was found in CO(2) laser treated patients versus IPL treated patients. No significant differences were seen in skin pigmentation% during the observation period. CONCLUSION: CO(2) laser resurfacing induces a significantly higher degree of clinical rhytide reduction followed by considerably more side effects compared to IPL rejuvenation in a homogeneous group of patients.