A Synergistic Approach to Remodeling of Photodamaegd Skin: Exploring Laser-Assisted Biostimulator Delivery

NCT07680426 | Not Yet Recruiting DMC

• 1 other identifier: 16-0302-103
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

Photodamaged skin increases the risk of skin cancer, highlighting the need for preventive treatments. Laser-assisted drug delivery (LADD) using ablative fractional lasers (AFL) enhances topical drug delivery and has proven safe and effective. Integrating non-invasive optical imaging techniques with transcriptomic gene expression profiling enables evaluation of the response of different skin layers to such interventions. It is hypothesized that AFL-assisted delivery of biostimulators exerts synergistic regenerative effects on photodamaged skin, resulting in superior clinical, molecular, and morphological improvements, as well as enhanced epidermal and dermal remodeling, compared with either monotherapy alone. The study aims to provide an in-depth understanding of the individual and combined effects of AFL and biostimulators on the regeneration of photodamaged skin through clinical assessments, non-invasive imaging, and transcriptomic analysis.

Conditions

Photodamaged Skin; Skin Cancer Prevention

Keywords

laser-assisted drug delivery; optical coherence tomography; poly-l-lactic acid; transcriptomics; ablative fractional laser; Photodamaged skin; skin cancer prevention; sculptra; skin diseases; non-invasive imaging

Outcome Measures

Primary Outcomes (1)

• Clinical efficacy

  Change from baseline in the overall clinical appearance of photodamage in the treated area will be assessed using a 5-point Global Improvement Score (GIS) ranging from 0 to 4, where 0 indicates no improvement and 4 indicates \>75 % improvement. Assessments will be performed by the on-site investigator and independent blinded physicians based on standardized clinical photographs.

  Baseline to Week 36

Secondary Outcomes (5)

• Transcriptomic response

  Baseline to Week 36

• Safety of interventions

  Baseline to week 36

• Pain assessment

  Baseline to Week 36

• Patient-reported improvement

  From baseline to Week 36

• Patient satisfaction

  Baseline to Week 36

Study Arms (3)

Laser-assisted PLLA delivery

EXPERIMENTAL

AFL treatment followed by immediate topical application of PLLA

Device: Ablative fractional laser; Device: Poly-L-Lactic Acid

AFL treatment

ACTIVE COMPARATOR

Treatment with AFL alone

Device: Ablative fractional laser

Control

NO INTERVENTION

No treatment

Interventions

Ablative fractional laser DEVICE

Treatment with AFL on the dorsal part of hand

Also known as: AFL, CO2 Laser

AFL treatment; Laser-assisted PLLA delivery

Poly-L-Lactic Acid DEVICE

Following AFL, PLLA will be applied to the same area

Also known as: Sculptra, PLLA

Laser-assisted PLLA delivery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• Clinical signs of photodamage. Signs will include low-grade actinic keratoses (Olsen grade I-II), solar lentigines, telangiectasia, or other visible markers of chronic photodamage.

You may not qualify if:

• Active skin diseases in the treatment site
• Laser treatment, PLLA, or other treatments in the treatment area within the past 24 months
• Pregnancy or breastfeeding
• Contraindications to AFL or Sculptra

Sponsors & Collaborators

• Bispebjerg Hospital: lead

Study Sites (1)

Bispebjerg Hospital

Copenhagen, Capital Region, 2400, Denmark

Location

MeSH Terms

Conditions

Skin Diseases

Interventions

Lasers, Gas

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinded assessors will be reviewing and scoring the clinical photos after the study is completed.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD, PhD, DMSc

Model Details: This study is designed as a prospective, randomized, within-subject, translational exploratory study. Participants will receive treatment on the dorsal sides of both hands. Within each participant, one hand will be randomly assigned to treatment with AFL alone, while the contralateral hand will be assigned to treatment with AFL followed by immediate topical application of PLLA. Each hand will also include an untreated control site, allowing for intra-individual comparisons of treatment effects.

Study Record Dates

• First Submitted: June 11, 2026
• First Posted: July 2, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 2, 2026

Record last verified: 2026-06

Locations

DK (1)