Comparative Effectiveness of Long-Pulsed 1064-nm Nd:YAG and Fractional CO₂ Laser in Skin Rejuvenation

NCT07467954 | Recruiting DMC

• 1 other identifier: DV-202603.01
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Laser; Skin Rejuvenation

Outcome Measures

Primary Outcomes (4)

• Dermal Thickness

  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

  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

  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

  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

Study Arms (2)

Arm 1

EXPERIMENTAL

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.

Procedure: Fractional CO₂ laser

Arm 2

ACTIVE COMPARATOR

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.

Procedure: Long-pulsed 1064-nm Nd:YAG laser

Interventions

Fractional CO₂ laser PROCEDURE

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.

Arm 1

Long-pulsed 1064-nm Nd:YAG laser PROCEDURE

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.

Arm 2

Eligibility Criteria

• Age: 30 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male and female patients with skin aging classified as Glogau scale II-III
• Age 30-59 years.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitas Padjadjaran: lead

Study Sites (1)

Hasan Sadikin General Hospital

Bandung, West Java, 40161, Indonesia

RECRUITING

Study Officials

• Kartika Ruchiatan, M.D.

  Faculty of Medicine Universitas Padjadjaran Bandung

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmad R Ganiem, M.D., Ph.D

CONTACT

+62 878 2288 3773; rizalbdg@gmail.com

Kartika Ruchiatan, M.D.

CONTACT

+62 811 247932; kartika.ruchiatan@unpad.ac.id

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2026
• First Posted: March 12, 2026
• Study Start: October 14, 2025
• Primary Completion: March 10, 2026
• Study Completion: April 16, 2026
• Last Updated: March 12, 2026

Record last verified: 2026-03

Locations

ID (1)