N/A
Completed N=20
Efficacy of Periorbital Rejuvenation With a 1927 nm Diode Laser Treatment
Laser · Periorbital
Source: ClinicalTrials.gov NCT05811026 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcomePrimary: Change From Baseline in Texture Score at Visit 4 (End-of-study Session) — 0.25; -4.75 score on a scale — p=0.075
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.
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 | — |
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.
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. Informational only — not medical advice.