A Prospective Study on the Effectiveness and Safety Evaluation of Dual Wavelength Long-pulsed 755nm Alexandrite/1,064nm Nd:YAG for Treatment of Cutaneous Vascular Lesions

Not Applicable

Completed

• Conditions: Congenital malformations, deformations and chromosomal abnormalities

• Registration Number: KCT0005847
• Lead Sponsor: Yonsei University Health System, Severance Hospital

Brief Summary

The erythema index (EI) significantly decreased on both treated sides (LPAL 366.5?±?101.0 vs. 295.8?±?90.2, p?<?0.001, PDL 369.0?±?124.3 vs. 302.7?±?92.1, p?<?0.001) 1 month after fourth treatment (visit 5). Also 3 months after the fourth treatment (visit 6), the reduction in the EI was well maintained on both sides (LPAL 360.3?±?96.8 vs. 282.0?±?89.2, p?<?0.001, PDL 364.3?±?121.6 vs. 281.6?±?97.8, p?<?0.001). When comparing the improvement in the EI between the two groups, the percentage reduction in the EI on the LPAL-treated side was not inferior to the PDL-treated side (visit 5: LPAL 18.7?±?15.7% vs. PDL 16.4?±?12.9%, p?=?0.501 and visit 6: LPAL 21.7?±?13.9% vs. PDL 21.9?±?15.2%, p?=?0.943).

Detailed Description

Not available

Study Timeline

• Study Completion: 2022-01-07
• Results First Posted: 2022-10-02
• Last Update Posted: 6 March 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

1) Adults aged 19-65
2) Individuals with cutaneous vascular lesions (rosacea, nevus flammeus)
3) Individuals who understands the purpose and methods of this trial
4) Individuals who can regularly visit our hospital
5) Individuals who agrees to avoid any other dermatologic therapies other than our treatment material

Exclusion Criteria

1) Whom denies to participate
2) Pregnant women, breast feeding women
3) Subjects judged to be unsuitable by the person in charge of the clinical trial for the following conditions
?In case of infectious or inflammatory skin disease at the treatment site
?In case of pigmented skin diseases such as spots at the treatment site
?In case of keloid or collagen or elastic fiber disease
?In case of chronic wasting disease (asthma, diabetes, etc.)
?When there is a risk of bleeding by taking an anticoagulant
?In case of an autoimmune disease
?Person with psychiatric problems
?Person with acute illness
4) Other cases when it is difficult to conduct the clinical (ex. illiteracy, foreigners)

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified