- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07467954
Comparative Effectiveness of Long-Pulsed 1064-nm Nd:YAG and Fractional CO₂ Laser in Skin Rejuvenation
March 8, 2026 updated by: Universitas Padjadjaran
A Comparative Split-Face Study of Long-Pulsed 1064-nm Nd:YAG and Fractional CO₂ Laser for Skin Rejuvenation Based on Dermal Thickness, Skin Elasticity, Wrinkle Assessment, and Global Aesthetic Improvement Scale Scores
Skin rejuvenation is an effort to improve skin condition from the signs of skin aging.
Skin aging is a complex biological process influenced by intrinsic and extrinsic factors, leading to changes in the epidermis and dermis, including decreased collagen characterized by dermal thinning, as well as alterations in skin appearance such as laxity and wrinkles.
Laser therapy is one of the treatment modalities for skin rejuvenation, aiming to induce neocollagenesis and collagen remodeling, resulting in dermal thickening and improvement in skin appearance.
Fractional CO₂ laser is an ablative laser considered the gold standard therapy for skin rejuvenation, whereas Long Pulsed (LP) Nd:YAG 1064 nm is a nonablative laser that is also used for skin rejuvenation.
To date, there have been no studies evaluating the comparative effectiveness between fractional CO₂ laser and LP Nd:YAG 1064 nm for skin rejuvenation.
Therefore, research comparing the effectiveness of fractional CO₂ laser and LP Nd:YAG 1064 nm for skin rejuvenation is needed, assessed based on dermal thickness, skin elasticity, wrinkles, and Global Aesthetic Improvement Scale scores.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ahmad R Ganiem, M.D., Ph.D
- Phone Number: +62 878 2288 3773
- Email: rizalbdg@gmail.com
Study Contact Backup
- Name: Kartika Ruchiatan, M.D.
- Phone Number: +62 811 247932
- Email: kartika.ruchiatan@unpad.ac.id
Study Locations
-
-
West Java
-
Bandung, West Java, Indonesia, 40161
- Recruiting
- Hasan Sadikin General Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Male and female patients with skin aging classified as Glogau scale II-III
- Age 30-59 years.
Exclusion Criteria:
- Pregnant or breastfeeding women.
- Active smokers.
- Individuals with high levels of sun exposure.
- History of facial laser therapy, microdermabrasion, chemical peeling, botulinum toxin injection, microneedling, or skin booster injections within the past six months.
- Use of oral isotretinoin within the past six months.
- Use of topical retinoids or their derivatives, topical vitamin C, or other collagen-stimulating and skin-rejuvenating agents within the past two weeks.
- Use of oral vitamin C, collagen-stimulating supplements, antioxidants, or hormone therapy with skin-rejuvenating effects within the past one month.
- Presence of active facial skin inflammation.
- History of keloid formation.
- History of allergy to topical lidocaine anesthesia.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Arm 1
In this split-face study, each participant received fractional CO₂ laser treatment on one side of the face.
The treated side was randomly assigned.
The procedure was performed three times at one-month intervals.
|
Fractional CO₂ laser was applied to one randomized side of the face in a split-face design for skin rejuvenation.
Treatments were performed three times at one-month intervals.
The laser delivers fractional ablative microthermal zones to stimulate dermal remodeling and collagen production.
Treatment parameters were adjusted according to skin type and clinical indication.
|
|
Active Comparator: Arm 2
In the same participants, the contralateral side of the face received long-pulsed 1064-nm Nd:YAG laser treatment.
The side allocation was randomized.
The procedure was performed three times at one-month intervals.
|
Long-pulsed 1064-nm Nd:YAG laser was applied to the contralateral randomized side of the face in a split-face design for skin rejuvenation.
Treatments were performed three times at one-month intervals.
The laser delivers non-ablative dermal heating to stimulate collagen remodeling and improve skin texture and elasticity.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dermal Thickness
Time Frame: From enrollment to the end of treatment at 20 weeks
|
Dermal thickness was assessed based on the two-dimensional area of the hyperechoic band that appears brighter than the epidermis on ultrasonography assessment.
|
From enrollment to the end of treatment at 20 weeks
|
|
Skin Elasticity
Time Frame: From enrollment to the end of treatment at 20 weeks
|
Skin elasticity was defined as the ability of the skin to return to its original shape after deformation caused by mechanical traction.
It was measured using a skin elasticity meter, and the R (recovery) value was assessed at 8 evaluation points on the face.
|
From enrollment to the end of treatment at 20 weeks
|
|
Wrinkles
Time Frame: From enrollment to the end of treatment at 20 weeks
|
Lines or folds formed on the skin surface as a result of mechanical stress, skin dehydration, or repetitive muscular activity, and were evaluated using a facial skin analyzer
|
From enrollment to the end of treatment at 20 weeks
|
|
Global Aesthetic Improvement Scale Scores
Time Frame: From enrollment to the end of treatment at 20 weeks
|
A 5-point rating scale (1-5) used to measure the degree of aesthetic improvement in patients following a procedure.
|
From enrollment to the end of treatment at 20 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kartika Ruchiatan, M.D., Faculty of Medicine Universitas Padjadjaran Bandung
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 14, 2025
Primary Completion (Estimated)
March 10, 2026
Study Completion (Estimated)
April 16, 2026
Study Registration Dates
First Submitted
March 8, 2026
First Submitted That Met QC Criteria
March 8, 2026
First Posted (Actual)
March 12, 2026
Study Record Updates
Last Update Posted (Actual)
March 12, 2026
Last Update Submitted That Met QC Criteria
March 8, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- DV-202603.01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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