Treatment of Leg Telangiectasias With Nd:YAG 1064nm

Telangiectasias Clinical Trial

Official title:

Treatment of Leg Telangiectasias With Nd:YAG 1064nm

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01118390
• Other study ID #: 0072/09
• Status: Enrolling by invitation
• Phase: N/A
• First received: April 29, 2010
• Last updated: May 5, 2010
• Start date: August 2009
• Est. completion date: July 2010

Study information

• Verified date: August 2009
• Source: Grupo de Cirurgia Vascular
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

Studying the results of treatment of dilated vessels of the lower limbs with laser, and compare them to those obtained with sclerotherapy.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Est. completion date: July 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Patients with leg telangiectasias

Exclusion Criteria:

• Arterial disease

• Varices

• Diabetes

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Telangiectasias
• Telangiectasis

Intervention

Device:
• Laser Nd:YAG 1064nm
Patients with leg telangiectasias are treated with 3 sessions of Nd:YAG 1064nm, with 14 days interval

Other:
• Sclerotherapy
Patients with leg telangiectasias are treated with 3 sessions of sclerotherapy, with 14 days interval

Locations

Country	Name	City	State
Brazil	Hospital das Clinicas da FMUSP	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Grupo de Cirurgia Vascular

Country where clinical trial is conducted

Brazil, 

References & Publications (4)

Anderson RR, Parrish JA. Selective photothermolysis: precise microsurgery by selective absorption of pulsed radiation. Science. 1983 Apr 29;220(4596):524-7. — View Citation

Bäumler W, Ulrich H, Hartl A, Landthaler M, Shafirstein G. Optimal parameters for the treatment of leg veins using Nd:YAG lasers at 1064 nm. Br J Dermatol. 2006 Aug;155(2):364-71. Review. — View Citation

Coles CM, Werner RS, Zelickson BD. Comparative pilot study evaluating the treatment of leg veins with a long pulse ND:YAG laser and sclerotherapy. Lasers Surg Med. 2002;30(2):154-9. — View Citation

Dudelzak J, Hussain M, Goldberg DJ. Vascular-specific laser wavelength for the treatment of facial telangiectasias. J Drugs Dermatol. 2009 Mar;8(3):227-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	treatment of leg telangiectasias	Patients respond after treatment a questionnaire about satisfaction for both the laser and for conventional sclerotherapy.	first day	No
Primary	Treatment of telangiectasias	Patients respond after treatment a questionnaire about satisfaction for both the laser and for conventional sclerotherapy.	1 month	No
Secondary	Presence of adverse effects	Patients are monitored to adverse effects such as blemishes, scars and ulcers	after 1 month	Yes
Secondary	Pain Scores on the Visual Analog Scale	Patients evaluate pain on the Visual Analog Scale	After 1 month	No