Comparative Effectiveness of Long-Pulsed 1064-nm Nd:YAG and Fractional CO₂ Laser in Skin Rejuvenation
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
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
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
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-
West Java
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Bandung, West Java, Indonesia, 40161
- Recruiting
- Hasan Sadikin General Hospital
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-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
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
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / 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
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
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Kartika Ruchiatan, M.D., Faculty of Medicine Universitas Padjadjaran Bandung
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
Other Study ID Numbers
- DV-202603.01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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