Photodamaged SkinPhase 4NCT03573076
Treatment of Photodamaged Skin of the décolleté
A Phase 4 study testing Photodynamic therapy, Non-ablative Thulium laser (NAFL) and Radio-frequency microneedles (RF-MN) in people with Photodamaged Skin, run by Merete Haedersdal at 1 site in Denmark.
Trial summary
This study investigates a non-ablative fractional thulium laser and a radio-frequency microneedling device as pre-treatment for combination photodynamic therapy in treatment of photoaged skin and actinic keratoses. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Photodamaged Skin
- What is being tested?
- Photodynamic therapy, Non-ablative Thulium laser (NAFL) and Radio-frequency microneedles (RF-MN)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteDenmark
- Study dates
- 10 Sep 2018to 18 Dec 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Décolleté with chronic field-change photodamaged skin.
- Area with visually homogenous photodamage.
- Provide informed written consent.
- Fertile women must provide a negative U-hCG pregnancy test at the time of inclusion, and use safe anticontraceptive during the entire study period, e.g. oral hormonal contraceptives, intrauterine devices, subdermal implantation, or hormonal vaginal ring.
Who cannot join
- Treatment of actinic keratoses in the décolleté area within the last 30 days.
- Porphyria.
- Pregnant or nursing women.
- Skin cancer (invasive, in situ), keratoacanthoma, or other infiltrating tumors in the study area.
- Known tendencies to produce hypertrophic scarring or keloids.
- Allergies against Metvix creme solution, peanuts, or soy.
- Considered unable to follow the study protocol, e.g. alcohol dependence syndrome.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Photodamaged Skin of the décolleté With Fractional Laser, Radio-frequency Microneedling, and Photodynamic Therapy
This study investigates a non-ablative fractional thulium laser and a radio-frequency microneedling device as pre-treatment for combination photodynamic therapy in treatment of photoaged skin and actinic keratoses.
Read the detailed description
Photoaging of skin and actinic keratoses Photoaging of the skin is the result of UV radiation in chronic sun exposure and its deleterious effects. Photoaging includes fine and coarse wrinkles, roughness, laxity, mottled pigmentation, coarseness, sallowness, telangiectasia, solar lentigines and dysplastic actinic keratoses. The process can be of both cosmetic and medical importance. Actinic keratoses (AK) are common dysplastic pre-malignant lesions that may develop into a malign invasive squamous cell carcinomas (SCC). SCCs have metastatic potential at up to 3%. The risk of malign transformation from AK to SCC is highest in chronic sun-damaged skin with confluent field-cancerization from multiple AK. National guidelines recommend treatment of the entire field of sun damaged skin with photodynamic therapy and several topical drugs, e.g. imiquimod, diclofenac, ingenol mebutate, and 5-fluoruracil. Repeat treatments are usually necessary to achieve the desired results in patients with chronic sun damaged skin.
Photochemical treatment with photodynamic therapy
Photodynamic therapy (PDT) is a treatment that uses a photosensitizer drug activated in the skin by light in the visible spectrum. Methyl aminolevulinate (MAL) is a photosensitizing agent with great affinity for dysplastic cells, and transforms into the light-sensitive Protoporphyrin PpIX. When exposed to light, photoactivated PpIX catalyzes a reactive oxygen species reaction, which leads to irreversible cell apoptosis of the dysplastic or neoplastic tissue. PDT can be used as treatment of a wide range of photoaging skin defects including actinic keratoses, and is exceedingly well suited for treatment of larger skin areas. PDT produces cosmetically pleasing results in extension of the excellent AK clearance.
Physical intervention with fractional laser and light-based interventions
Fractional laser and light-based treatments with lasers and microneedles are approaches that can be applied very precisely, and can be used to rejuvenate photodamaged skin.
Laser-treatment for rejuvenation of skin can be achieved using a non-ablative 1927 nm fractionated thulium laser (NAFL), good results have been reported for many aspects of photoaging, and specifically for actinic keratoses with good results. The thulium laser works by creating vertical thermal laser-channels in the skin without the ablative effect to the epidermis. Laser-treatment with the thulium laser may be combined with other treatments like PDT to produce synergistic effects.
Microneedling (MN) is a treatment option in which the skin epidermis is penetrated by closely arranged multiple microneedles. This can induce collagen production and stimulate the release of growth factors, and collagen synthesis and remodeling, producing the effects of rejuvenation. Radio-frequency (RF) microneedling (MN), also known as RF-MN, adds RF making it possible for insulated needles to emit heat at the needle-heads when the epidermis is fully punctured, possibly enhancing the described effects even further. Good results have been reported using MN as skin rejuvenation, and can the treatment be used in conjunction with PDT.
The delicate skin of the décolleté is subject to a high amount of accumulated life-time sun exposure, and is thus highly susceptible to photoaging effects. A mild and effective treatment of photodamaged skin for this particular area is highly desirable, and may be achieved by developing new combination strategies, in which the thulium laser or a microneedling device can be used as effective pre-treatment for PDT. To our knowledge, no previous randomized study has compared the use of the non-ablative thulium laser or microneedling in combination with photodynamic treatment (PDT).
- Conditions
- Photodamaged Skin
- Being tested
- Photodynamic therapy, Non-ablative Thulium laser (NAFL), Radio-frequency microneedles (RF-MN)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photodynamic therapyCombination product
Photodynamic therapy with Methyl Aminolevulinate creme and red light.
Non-ablative Thulium laser (NAFL)Device
Non-ablative Thulium laser (NAFL).
Radio-frequency microneedles (RF-MN)Device
Radio-frequency microneedles (RF-MN).
| Study group | Role | What they receive |
|---|---|---|
| Thulium laser + photodynamic therapy | Experimental | Non-ablative Thulium laser (NAFL) + Photodynamic therapy combination treatment Receives: Combination Product: Photodynamic therapy; Device: Non-ablative Thulium laser (NAFL) |
| RF microneedles + photodynamic therapy | Experimental | Radio-frequency microneedles (RF-MN) + Photodynamic therapy combination treatment Receives: Combination Product: Photodynamic therapy; Device: Radio-frequency microneedles (RF-MN) |
| Non-ablative Thulium laser | Active comparator | Non-ablative Thulium laser (NAFL) single treatment Receives: Device: Non-ablative Thulium laser (NAFL) |
| RF microneedles | Active comparator | Radio-frequency microneedles (RF-MN) single treatment Receives: Device: Radio-frequency microneedles (RF-MN) |
| Control | No intervention | Control receiving no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical improvement of photodamage
5-point categorial scale of photodamage severity, measuring changes in skin texture, pigmentation, telangiectasia, and wrinkles. Scores are 0, 1, 2, 3, and 4, for none, mild, moderate, severe, and very severe, respectively. A reduction in score from initial scoring to post-treatment is desirable.
Measured: 12 weeks
Secondary outcomes (6)
Treatment effect on actinic keratoses
Evaluated on the Olsen grading scale for actinic keratoses thickness. Scores are 1, 2, and 3, for slightly palpable, moderately thick, and very thick and hyperkeratotic, respectively. A reduction in score from initial scoring to post-treatment is desirable.
Measured: 12 weeks
Severity of local skin reactions
Local skin reaction (LSR)-grading scale. Evaluation of redness, scaling, edema, pustules, and erosion on a 5-point categorial scale of severity. Scores are 0, 1, 2, 3, and 4, for individual parameters:
Redness: None, slightly pink <50%, pink or light red >50%, red restricted to treatment area, and red extending outside treatment area.
Scaling: None, isolated scale, scaling <50%, scaling >50%, scaling extending outside treatment area.
Edema: None, slight specific edema, palpable edema beyond individual lesions, confluent and/or visible edema, and marked swelling extending outside treatment area.
Pustules: None, vesicles only, transudate or pustules <50%, transudate or pustules >50%, and transudate or pustules extending outside treatment area.
Erosion: None, lesion specific erosion, erosion extending beyond individual lesion, erosion >50%, and black eschar or ulceration.
Measured: 7 days
Presence of perceived pain during treatment
VAS Visual analogue scale for perceived pain. Scores are 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10, ranging from none to very severe. Higher is worse, and lower scores for treatment modalities are desirable.
Measured: 0 days
Cosmetic results
Cosmetic results on a 5-point categorial scale for perceived cosmetic outcome compared with base starting point for the individual patient. Scores are 0, 1, 2, 3, and 4, for poor, acceptable, good, excellent, and outstanding, respectively. A higher score is desirable.
Measured: 12 weeks
Protoporphyrin IX (PpIX) fluorescence uptake
Levels of PpIX uptake in the skin computed quantitatively from PpIX imaging. Imaging before application, after 3 hours, and after LED exposure.
Measured: 0 days
Safety including wounding, scarring, hyper and hypo pigmentation
Safety concerning side-effects evaluated on a 5-point categorial scale for hyper- and hypopigmentation, erosions, and scarring. Scores are 0, 1, 2, 3, and 4, for none, mild, moderate, severe, and very severe. A lower score is desirable.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2018
- Study start10 Sep 2018
- Primary completion18 Dec 2018
- Study completion18 Dec 2018
Why it stopped: The second study arm including radio-frequency microneedling was withdrawn due to availability of newer treatment options.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Photodamaged SkinStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merete Haedersdal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Merete Haedersdal, Bispebjerg Hospital
- Investigators
- Merete Haedersdal, MD, Principal investigator, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03573076
- Sponsor's protocol ID
- 2018-000189-12
- Other IDs
- 2018
- Status last verified
- Jul 2020
- First submitted
- 6 Jun 2018
- Last updated
- 10 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Photodamaged Skin of the décolleté With Fractional Laser, Radio-frequency Microneedling, and Photodynamic Therapy
- ClinicalTrials.gov ID
- NCT03573076
- Acronym / sponsor ID
- 2018-000189-12
- Conditions
- Photodamaged Skin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The second study arm including radio-frequency microneedling was withdrawn due to availability of newer treatment options.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Merete HaedersdalUniversity, hospital or other
- Study start
- 10 Sep 2018 (actual)
- Primary completion
- 18 Dec 2018 (actual)
- Study completion
- 18 Dec 2018 (actual)
- First posted
- 29 Jun 2018 (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.
This study investigates a non-ablative fractional thulium laser and a radio-frequency microneedling device as pre-treatment for combination photodynamic therapy in treatment of photoaged skin and actinic keratoses.
Detailed description
Photoaging of skin and actinic keratoses Photoaging of the skin is the result of UV radiation in chronic sun exposure and its deleterious effects. Photoaging includes fine and coarse wrinkles, roughness, laxity, mottled pigmentation, coarseness, sallowness, telangiectasia, solar lentigines and dysplastic actinic keratoses. The process can be of both cosmetic and medical importance. Actinic keratoses (AK) are common dysplastic pre-malignant lesions that may develop into a malign invasive squamous cell carcinomas (SCC). SCCs have metastatic potential at up to 3%. The risk of malign transformation from AK to SCC is highest in chronic sun-damaged skin with confluent field-cancerization from multiple AK. National guidelines recommend treatment of the entire field of sun damaged skin with photodynamic therapy and several topical drugs, e.g. imiquimod, diclofenac, ingenol mebutate, and 5-fluoruracil. Repeat treatments are usually necessary to achieve the desired results in patients with chronic sun damaged skin.
Photochemical treatment with photodynamic therapy
Photodynamic therapy (PDT) is a treatment that uses a photosensitizer drug activated in the skin by light in the visible spectrum. Methyl aminolevulinate (MAL) is a photosensitizing agent with great affinity for dysplastic cells, and transforms into the light-sensitive Protoporphyrin PpIX. When exposed to light, photoactivated PpIX catalyzes a reactive oxygen species reaction, which leads to irreversible cell apoptosis of the dysplastic or neoplastic tissue. PDT can be used as treatment of a wide range of photoaging skin defects including actinic keratoses, and is exceedingly well suited for treatment of larger skin areas. PDT produces cosmetically pleasing results in extension of the excellent AK clearance.
Physical intervention with fractional laser and light-based interventions
Fractional laser and light-based treatments with lasers and microneedles are approaches that can be applied very precisely, and can be used to rejuvenate photodamaged skin.
Laser-treatment for rejuvenation of skin can be achieved using a non-ablative 1927 nm fractionated thulium laser (NAFL), good results have been reported for many aspects of photoaging, and specifically for actinic keratoses with good results. The thulium laser works by creating vertical thermal laser-channels in the skin without the ablative effect to the epidermis. Laser-treatment with the thulium laser may be combined with other treatments like PDT to produce synergistic effects.
Microneedling (MN) is a treatment option in which the skin epidermis is penetrated by closely arranged multiple microneedles. This can induce collagen production and stimulate the release of growth factors, and collagen synthesis and remodeling, producing the effects of rejuvenation. Radio-frequency (RF) microneedling (MN), also known as RF-MN, adds RF making it possible for insulated needles to emit heat at the needle-heads when the epidermis is fully punctured, possibly enhancing the described effects even further. Good results have been reported using MN as skin rejuvenation, and can the treatment be used in conjunction with PDT.
The delicate skin of the décolleté is subject to a high amount of accumulated life-time sun exposure, and is thus highly susceptible to photoaging effects. A mild and effective treatment of photodamaged skin for this particular area is highly desirable, and may be achieved by developing new combination strategies, in which the thulium laser or a microneedling device can be used as effective pre-treatment for PDT. To our knowledge, no previous randomized study has compared the use of the non-ablative thulium laser or microneedling in combination with photodynamic treatment (PDT).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Thulium laser + photodynamic therapy | Experimental | Combination Product: Photodynamic therapy, Device: Non-ablative Thulium laser (NAFL)Non-ablative Thulium laser (NAFL) + Photodynamic therapy combination treatment |
| RF microneedles + photodynamic therapy | Experimental | Combination Product: Photodynamic therapy, Device: Radio-frequency microneedles (RF-MN)Radio-frequency microneedles (RF-MN) + Photodynamic therapy combination treatment |
| Non-ablative Thulium laser | Active comparator | Device: Non-ablative Thulium laser (NAFL)Non-ablative Thulium laser (NAFL) single treatment |
| RF microneedles | Active comparator | Device: Radio-frequency microneedles (RF-MN)Radio-frequency microneedles (RF-MN) single treatment |
| Control | No intervention | –Control receiving no intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Décolleté with chronic field-change photodamaged skin.
- Area with visually homogenous photodamage.
- Provide informed written consent.
- Fertile women must provide a negative U-hCG pregnancy test at the time of inclusion, and use safe anticontraceptive during the entire study period, e.g. oral hormonal contraceptives, intrauterine devices, subdermal implantation, or hormonal vaginal ring.
Key exclusion criteria (7 listed)
- Treatment of actinic keratoses in the décolleté area within the last 30 days.
- Porphyria.
- Pregnant or nursing women.
- Skin cancer (invasive, in situ), keratoacanthoma, or other infiltrating tumors in the study area.
- Known tendencies to produce hypertrophic scarring or keloids.
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 |
|---|---|---|
| Photodynamic therapyPhotodynamic therapy with Methyl Aminolevulinate creme and red light. | Combination product | RF microneedles + photodynamic therapy, Thulium laser + photodynamic therapy |
| Non-ablative Thulium laser (NAFL)Non-ablative Thulium laser (NAFL). | Device | Non-ablative Thulium laser, Thulium laser + photodynamic therapy |
| Radio-frequency microneedles (RF-MN)Radio-frequency microneedles (RF-MN). | Device | RF microneedles, RF microneedles + photodynamic therapy |
Primary outcome
Clinical improvement of photodamage
Time frame: 12 weeks
5-point categorial scale of photodamage severity, measuring changes in skin texture, pigmentation, telangiectasia, and wrinkles. Scores are 0, 1, 2, 3, and 4, for none, mild, moderate, severe, and very severe, respectively. A reduction in score from initial scoring to post-treatment is desirable.
6 secondary outcomes
Treatment effect on actinic keratoses
Time frame: 12 weeks
Severity of local skin reactions
Time frame: 7 days
Presence of perceived pain during treatment
Time frame: 0 days
Cosmetic results
Time frame: 12 weeks
Protoporphyrin IX (PpIX) fluorescence uptake
Time frame: 0 days
Safety including wounding, scarring, hyper and hypo pigmentation
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: The second study arm including radio-frequency microneedling was withdrawn due to availability of newer treatment options.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2020.
- Individual participant dataSharing planned: No
Related trials for Photodamaged Skin
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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. This study is not recruiting at the moment.
Merete Haedersdal, MD principal investigator
Bispebjerg Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Photodynamic therapy, Non-ablative Thulium laser (NAFL) and Radio-frequency microneedles (RF-MN) in people with Photodamaged Skin, 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 4 inclusion and 7 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: stopped early, as of the sponsor's last update on 10 Jul 2020. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The second study arm including radio-frequency microneedling was withdrawn due to availability of newer treatment options.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical improvement of photodamage (time frame: 12 weeks). 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 10 Jul 2020.