Long Pulse 1064 nm Nd:YAG Laser in the Treatment of Erythematotelangiectatic Rosacea and Other Erythematous Telangiectatic Facial Conditions (Nd:YAG)

The goal of this clinical study is to assess the effectiveness of Nd:YAG laser 1064 nm in the long pulse mode in the treatment of signs of rosacea including the erythema of the face and telangiectasia. The used parameter of this laser was of very low energy (spot size: 5mm, fluence: 4.07 J/Cm2, energy: 800 millijoules (mJ) and frequency: 5 Hz. About 2-3 passes performed in each treatment session. Up to four sessions were performed for each patient with 2 weeks interval) and also its was expected to have minimal adverse effects.

Study Overview

• Status: Completed
• Conditions: Rosacea, Erythematotelangiectatic
• Intervention / Treatment: Device: Nd:YAG laser 1064 nm

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iraq
  • Erbil, Iraq, 44001
    • Hawler Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient with rosacea (erythemato-telangiectatic type)

Exclusion Criteria:

• Other clinical types of rosacea
• Pregnancy and lactation in females
• History of malignancies
• History of photosensitivity
• History of any other modalities of treatment of rosacea over last 6 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Definition: rosacea patients. Limit: 30 patients; Patients with rosacea received treatment with Nd:YAG laser with spot size: 5mm, fluence: 4.07 J/Cm2, energy: 800 mJ and frequency: 5 Hz. About 2-3 passes performed in each treatment session. Up to four sessions were performed for each patient with 2 weeks interval	Device: Nd:YAG laser 1064 nm; The entire face of each patient with rosacea was treated with long-pulse 1064nm Nd:YAG laser. The parameters that been used were spot size: 5mm, fluence: 4.07 J/Cm2, energy: 800 mJ and frequency: 5 Hz. About 2-3 passes performed in each treatment session. Up to four sessions were performed for each patient with 2 weeks interval.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in erythema of face of patients with rosacea been treated by ND:YAG laser 1064 nm long pulse width by using clinician erythema scale (CEA)	Erythema was graded from 0 to 4 using clinician erythema assessment scale (CEA). The score 0 is the lowest score of erythema and score 4 means the highest severity of erythema of the skin	Three months

Collaborators and Investigators

• Sponsor: Hawler Medical University

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2023
• Primary Completion (Actual): November 1, 2023
• Study Completion (Actual): November 4, 2024

Study Registration Dates

• First Submitted: December 28, 2024
• First Submitted That Met QC Criteria: April 1, 2025
• First Posted (Actual): April 3, 2025

Study Record Updates

• Last Update Posted (Actual): April 3, 2025
• Last Update Submitted That Met QC Criteria: April 1, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Nd:YAG laser
• Additional Relevant MeSH Terms: Skin Diseases; Rosacea
• Other Study ID Numbers: KHCMS: 12/241-2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No