Clinical trial · Interventional
Multimodal Laser Treatment of Photodamaged Skin
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 10, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260910-000001
Summary
Brief summary (as posted)
The Multimodal Laser Project is a prospective, randomized, split-face clinical study investigating a novel combination of laser and light-based treatments for facial photodamage with the long-term perspective of improving skin cancer prevention. The study includes 35 patients with facial photodamage and AKs. One side of the face receives a multimodal treatment combining three complementary technologies: 1927-nm thulium laser, 1550-nm non-ablative fractional laser, and intense pulsed light (IPL), while the contralateral side serves as an untreated control. Participants are followed for 14 months to assess both clinical efficacy and longer-term preventive effects. The overall aim is not only to determine whether multimodal laser treatment improves photodamaged skin, but also to gain a deeper understanding of how the treatment affects the underlying biology of chronically sun-damaged skin and its potential role in skin cancer prevention.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Actinic Keratosis (AK) | — | UNRESOLVED | — |
| Photo-damage | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 1550-nm Er:Glass laser | Device | — | UNRESOLVED |
| 1927-nm thulium laser | Device | — | UNRESOLVED |
| Intense Pulsed Light | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Multimodal treatment
- description
- Multimodal treatment with 1927-nm thulium laser + 1550-nm non-ablative fractional laser (NAFL) + intense pulsed light (IPL)
- interventionNames
- Device: 1927-nm thulium laser
- Device: 1550-nm Er:Glass laser
- Device: Intense Pulsed Light
- type
- NO_INTERVENTION
- label
- Control
- description
- No treatment
Primary outcomes (1)
- measure
- Clinical improvement
- timeFrame
- Baseline to Week 60
- description
- Change from baseline in the overall clinical appearance of facial photodamage will be assessed using a 5-point Global Aesthetic Improvement Scale (GAIS) based on standardized clinical photographs and on-site evaluation. Assessments will be performed by the site investigator and independent blinded physicians. The scale ranges from 1 to 5, where 1 = very much improved and 5 = worse. Lower scores indicate greater clinical improvement.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥18 years * Clinical signs of facial photodamage, including low-grade actinic keratosis (Olsen grade I-II) , solar lentigines, mottled hyper- and hypopigmentation, telangiectasia, skin thinning or atrophy, loss of skin elasticity (solar elastosis), coarse, leathery texture Exclusion Criteria: * Fitzpatrick skin type ≥ 4 * Active skin disease in the treatment area that may interfere with study treatment or assessments * Cosmetic treatments in the face within the last 12 months, including but not limited to chemical peels, injectables, and light- or laser-based treatments * Pregnancy or breastfeeding * Contraindications to the three lasers or topical anesthetics * Fitzpatrick skin type ≥ 4 * Active skin disease in the treatment area that may interfere with study treatment or assessments * Cosmetic treatments in the face within the last 12 months, including but not limited to chemical peels, injectables, and light- or laser-based treatments * Pregnancy or breastfeeding * Contraindications to the three lasers or topical anesthetics
References
Publications (0)
Data not yet available