NCT07678697

Brief Summary

This study aims to compare the efficacy (in terms of vein clearance) and safety of Nd:YAG laser combined with injection sclerotherapy versus diode laser combined with injection sclerotherapy in the treatment of reticular veins and telangiectasias using the Cryo-Laser and Cryo-Sclerotherapy (CLaCS) technique.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
4mo left

Started Jun 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress34%
Jun 2026Dec 2026

Study Start

First participant enrolled

June 1, 2026

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

June 25, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 1, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

July 1, 2026

Status Verified

June 1, 2026

Enrollment Period

6 months

First QC Date

June 25, 2026

Last Update Submit

June 25, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Degree of vein clearance

    Degree of vein clearance will be assessed by immediate endpoint response during laser application, defined as either instantaneous disappearance of the vein or an immediate change in vein color.

    6 months postoperatively

Secondary Outcomes (5)

  • Degree of pain

    6 months postoperatively

  • Degree of patient satisfaction

    6 months postoperatively

  • Incidence of complications

    6 months postoperatively

  • Number of treatment sessions required

    6 months postoperatively

  • Recurrence rate

    6 months postoperatively

Study Arms (2)

Group A (Nd:YAG Group):

EXPERIMENTAL

Patients will receive Nd:YAG laser (1064 nm) + injection sclerotherapy (CLaCS).

Device: Nd:YAG laser

Group B (Diode Group)

EXPERIMENTAL

Patients will receive Diode laser (980 nm) + injection sclerotherapy (CLaCS).

Drug: Diode laser

Interventions

Patients will receive Nd:YAG laser (1064 nm) + injection sclerotherapy (CLaCS).

Group A (Nd:YAG Group):

Patients will receive Diode laser (980 nm) + injection sclerotherapy (CLaCS).

Group B (Diode Group)

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients aged 18-60 years.
  • Both sexes.
  • Presence of reticular veins and/or telangiectasias (CEAP classification C1).
  • Fitzpatrick skin types II-V.
  • Patients seeking cosmetic treatment.

You may not qualify if:

  • Pregnancy or lactation.
  • History of deep vein thrombosis.
  • Coagulation disorders.
  • Allergy to sclerosant agents.
  • Active skin infection at treatment site.
  • Previous treatment of target veins within 6 months.
  • Great saphenous vein or short saphenous vein incompetence.
  • Deep venous insufficiency or thrombosis.
  • Abnormal venous duplex findings.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University

Cairo, 11591, Egypt

RECRUITING

MeSH Terms

Conditions

Telangiectasis

Interventions

Lasers, Semiconductor

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

LasersOptical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Vascular Surgery, Faculty of Medicine, Ain Shams University, Cairo, Egypt.

Study Record Dates

First Submitted

June 25, 2026

First Posted

July 1, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

July 1, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will share

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Shared Documents
STUDY PROTOCOL
Time Frame
After the end of study for one year.
Access Criteria
The data will be available upon a reasonable request from the corresponding author.

Locations