N/A N=20 Randomized Treatment

Efficacy of Periorbital Rejuvenation With a 1927 nm Diode Laser Treatment

Laser · Periorbital

Bottom Line

View on ClinicalTrials.gov: NCT05811026 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2025

Primary outcome: Primary: Change From Baseline in Texture Score at Visit 4 (End-of-study Session) — 0.25; -4.75 score on a scale — p=0.075

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Periorbital rejuvenation with a 1927 nm diode laser treatment (2-week interval) (Device); Periorbital rejuvenation with a 1927 nm diode laser treatment (4-week interval) (Device)
Age: Adult, Older Adult · 30+ yrs
Sex: All
Sponsor: National Taiwan University Hospital
Primary completion: Jun 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Texture Score at Visit 4 (End-of-study Session)	0.25; -4.75	0.075
SECONDARY Change From Baseline in Color Measurements (L*) at Visit 4 (End-of-study Session)	-0.61495; -0.798575	0.4727
SECONDARY Change From Baseline in Pigmentation Score at Visit 4 (End-of-study Session)	-9; -7.5	0.7326
SECONDARY Change From Baseline in Pores' Index at Visit 4 (End-of-study Session)	-0.02675; -0.63555	0.0757
SECONDARY Change From Baseline in Wrinkles' Score at Visit 4 (End-of-study Session)	13; -29.75	0.0376 sig
SECONDARY Change From Baseline in Physician Assessment of Global Aesthetic Improvement Score (GAIS), at Visit 4 (End-of-study Session)	2.8; 3.0	0.3123
SECONDARY Change From Baseline in Patient Assessment of Global Aesthetic Improvement Score (GAIS), at Visit 4 (End-of-study Session)	3.0; 2.0	0.1009
SECONDARY Change From Baseline in Texture Score at Visit 2	1.5; -4	0.0088 sig
SECONDARY Change From Baseline in Color Measurements (L*) at Visit 2	-0.4711; -0.44215	0.4274
SECONDARY Change From Baseline in Pigmentation Score at Visit 2	-0.5; -2.25	0.6497
SECONDARY Change From Baseline in Pores' Index at Visit 2	0.126725; -0.4088	0.0006 sig
SECONDARY Change From Baseline in Wrinkles' Score at Visit 2	11; -23.5	0.0002 sig
SECONDARY Change From Baseline in Physician Assessment of Global Aesthetic Improvement Score (GAIS), at Visit 2	4.0; 4.0	0.6231
SECONDARY Change From Baseline in Patient Assessment of Global Aesthetic Improvement Score (GAIS), at Visit 2	3.0; 3.0	0.3327
SECONDARY Change From Baseline in Texture Score at Visit 3	2.75; -4.5	0.0752
SECONDARY Change From Baseline in Color Measurements (L*) at Visit 3	-1.1979; -0.26345	0.0982
SECONDARY Change From Baseline in Pigmentation Score at Visit 3	-3; -2.5	0.8541
SECONDARY Change From Baseline in Pores' Index at Visit 3	0.299125; -0.33025	0.0758
SECONDARY Change From Baseline in Wrinkles' Score at Visit 3	20.25; -21.5	0.066
SECONDARY Change From Baseline in Physician Assessment of Global Aesthetic Improvement Score (GAIS), at Visit 3	3.5; 3.7	0.6961
SECONDARY Change From Baseline in Patient Assessment of Global Aesthetic Improvement Score (GAIS), at Visit 3	3.0; 2.0	0.0067 sig
SECONDARY Visual Analogue Scale (VAS) During Treatment	5; 6.5	—

Summary

The purpose of this research project is to investigate the treatment design, therapeutic effects and safety of the 1927 nm laser for the rejuvenation of the skin around the eyes.

Eligibility Criteria

Inclusion Criteria

aged between 30 and 65 years old;
no significant skin lesions or inflammation on the facial skin;
willing and able to comply with study requirements, instructions, and restrictions;
signed informed consent form.

Exclusion Criteria

underwent facial active treatment, such as using laser, intense pulsed light, radiofrequency skin tightening, ultrasound skin tightening, botulinum toxin, or dermal fillers injection, within the previous six months;
have chronic skin diseases such as atopic dermatitis, psoriasis, chronic urticaria, vitiligo, rosacea, or keloid;
pregnant or breastfeeding;
suffered from acute illnesses or infections requiring treatment within 14 days before entering the study;
have had serious illnesses (such as heart disease, lung disease, brain disease, or liver disease) within the previous three months;
allergic to Lidocaine or Prilocaine used in topical anesthetic cream or suffer from methemoglobinemia;
used any skin medication on the face within 30 days before the trial, deemed by the principal investigator to affect the study results;
deemed unsuitable for the study by the principal investigator.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05811026). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.