NCT06908915

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

March 3, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 4, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 28, 2024

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 3, 2025

Completed
Last Updated

April 3, 2025

Status Verified

April 1, 2025

Enrollment Period

8 months

First QC Date

December 28, 2024

Last Update Submit

April 1, 2025

Conditions

Keywords

Nd:YAG laser

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Definition: rosacea patients. Limit: 30 patients

EXPERIMENTAL

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

Interventions

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.

Definition: rosacea patients. Limit: 30 patients

Eligibility Criteria

Age32 Years - 52 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patient with rosacea (erythemato-telangiectatic type)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hawler Medical University

Erbil, 44001, Iraq

Location

MeSH Terms

Conditions

Rosacea

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst Professor

Study Record Dates

First Submitted

December 28, 2024

First Posted

April 3, 2025

Study Start

March 3, 2023

Primary Completion

November 1, 2023

Study Completion

November 4, 2024

Last Updated

April 3, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will share

Locations