Photo-damageNCT07789002
Multimodal Laser Treatment of Photodamaged Skin
A study testing 1927-nm thulium laser, 1550-nm Er:Glass laser and Intense Pulsed Light in people with Photo-damage and Actinic Keratosis (AK), run by Merete Haedersdal at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Photo-damage, Actinic Keratosis (AK)
- What is being tested?
- 1927-nm thulium laser, 1550-nm Er:Glass laser and Intense Pulsed Light
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Sep 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Department of Dermatology, Bispebjerg Hospital
Copenhagen NV, 2400
Aqella Rasul, MD, 0045 71590063, aqella.rasul.01@regionh.dk
About this study
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.
Read more
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
- Photo-damage, Actinic Keratosis (AK)
- Being tested
- 1927-nm thulium laser, 1550-nm Er:Glass laser, Intense Pulsed Light
- Keywords
- laser, photodamaged skin, IPL, non-ablative fractional laser, fractional laser, Thulium laser, UV damage
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1927-nm thulium laserDevice
Also called fractional laser
Fractional non-ablative 1927-nm thulium laser treatment applied to the randomized intervention side of the face
1550-nm Er:Glass laserDevice
Also called non-ablative fractional laser
Fractional non-ablative 1550-nm Er:Glass laser treatment applied to the randomized intervention side of the face
Intense Pulsed LightDevice
Also called IPL
Intense pulsed light treatment applied to the randomized intervention side of the face
| Study group | Role | What they receive |
|---|---|---|
| Multimodal treatment | Experimental | Multimodal treatment with 1927-nm thulium laser + 1550-nm non-ablative fractional laser (NAFL) + intense pulsed light (IPL) Receives: Device: 1927-nm thulium laser; Device: 1550-nm Er:Glass laser; Device: Intense Pulsed Light |
| Control | No intervention | No treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical improvement
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.
Measured: Baseline to Week 60
Secondary outcomes (5)
Transcriptomic response
Changes in gene expression profiles will be assessed by transcriptomic analysis of tape-strip samples collected before and after treatment and compared between intervention arms.
Measured: Baseline to Week 60
Safety of interventions
Safety will be evaluated by the incidence, severity, and relationship to treatment of Adverse Events (AEs) and Serious Adverse Events (SAEs) throughout the study period. AEs and SAEs will be recorded continuously at each study visit and assessed by the investigator.
Measured: Baseline to Week 60
Pain assessment
Pain associated with each intervention will be assessed using a patient-reported Numeric Rating Scale (NRS) ranging from 1 to 10, where 1 indicates minimal pain and 10 indicates the worst imaginable pain.
Measured: Baseline to Week 60
Patient satisfaction
Patient satisfaction will be assessed using a 5-point satisfaction scale ranging from -2 to +2, where -2 indicates very dissatisfied, 0 indicates neutral, and +2 indicates very satisfied.
Measured: Baseline to Week 60
Change in Actinic Keratosis Count
Change from baseline in the total number of clinically identified actinic keratoses within the study area.
Measured: Baseline to Week 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Photo-damageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is designed as a prospective, randomized, split-face, within-subject exploratory study. Participants with facial photodamage will receive multimodal laser treatment on one randomly assigned side of the face, while the contralateral side will remain untreated and serve as an intra-individual control. The multimodal treatment combines three complementary laser and light-based modalities: 1927-nm thulium laser, 1550-nm non-ablative fractional laser, and intense pulsed light (IPL). This design allows for direct intra-individual comparison of treatment effects.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Merete Haedersdal
- Sponsor type
- University, hospital or other
- Collaborators
- CynosureLutronic, University of Copenhagen
- Responsible party
- Sponsor-investigator, Merete Haedersdal, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07789002
- Sponsor's protocol ID
- 16-0302-163
- Status last verified
- Sep 2026
- First submitted
- 24 Aug 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Laser Treatment of Photodamaged Skin
- ClinicalTrials.gov ID
- NCT07789002
- Acronym / sponsor ID
- 16-0302-163
- Conditions
- Photo-damage, Actinic Keratosis (AK)
- Keywords
- laser, photodamaged skin, IPL, non-ablative fractional laser, fractional laser, Thulium laser, UV damage
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Merete HaedersdalUniversity, hospital or other
- Collaborators
- CynosureLutronic, University of Copenhagen
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 27 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study is designed as a prospective, randomized, split-face, within-subject exploratory study. Participants with facial photodamage will receive multimodal laser treatment on one randomly assigned side of the face, while the contralateral side will remain untreated and serve as an intra-individual control. The multimodal treatment combines three complementary laser and light-based modalities: 1927-nm thulium laser, 1550-nm non-ablative fractional laser, and intense pulsed light (IPL). This design allows for direct intra-individual comparison of treatment effects.
| Arm | Type | Receives |
|---|---|---|
| Multimodal treatment | Experimental | Device: 1927-nm thulium laser, Device: 1550-nm Er:Glass laser, Device: Intense Pulsed LightMultimodal treatment with 1927-nm thulium laser + 1550-nm non-ablative fractional laser (NAFL) + intense pulsed light (IPL) |
| Control | No intervention | –No treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1927-nm thulium laserAlso: fractional laserFractional non-ablative 1927-nm thulium laser treatment applied to the randomized intervention side of the face | Device | Multimodal treatment |
| 1550-nm Er:Glass laserAlso: non-ablative fractional laserFractional non-ablative 1550-nm Er:Glass laser treatment applied to the randomized intervention side of the face | Device | Multimodal treatment |
| Intense Pulsed LightAlso: IPLIntense pulsed light treatment applied to the randomized intervention side of the face | Device | Multimodal treatment |
Primary outcome
Clinical improvement
Time frame: Baseline to Week 60
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.
5 secondary outcomes
Transcriptomic response
Time frame: Baseline to Week 60
Safety of interventions
Time frame: Baseline to Week 60
Pain assessment
Time frame: Baseline to Week 60
Patient satisfaction
Time frame: Baseline to Week 60
Change in Actinic Keratosis Count
Time frame: Baseline to Week 60
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: No
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Retinal Light Damage, Photic Retinopathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1927-nm thulium laser, 1550-nm Er:Glass laser and Intense Pulsed Light in people with Photo-damage and Actinic Keratosis (AK), run by Merete Haedersdal at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aqella Rasul, MD (0045 71590063, aqella.rasul.01@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical improvement (time frame: Baseline to Week 60). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.