Skin CancerNCT03775031
Chemical Peels and Fractional Laser on IGF-1 Levels in Skin
A study testing Fractional Laser and Chemical Peel in people with Skin Cancer, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the impact of fractional laser versus chemical peels on IGF-1 levels in skin. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Skin Cancer
- What is being tested?
- Fractional Laser and Chemical Peel
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2019to 1 Jul 2021
- 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 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female subjects >55 years old
- Fitzpatrick type I-II
- Able to provide informed consent.
- Cutaneous photodamage of 3 or above on the Larnier photodamage scale (see Appendix).
Who cannot join
- Prior laser or peel treatment in the area evaluated in the current study in the past year.
- Currently taking immunosuppressant medications known to interfere wound healing or anti-inflammatory medications (such as NSAIDs, or steroids).
- Subjects who have underlying diseases that could alter wound healing response (such as Diabetes).
- Currently taking insulin.
- History of substance abuse, mental dysfunction, or other factors limiting ability to cooperate with study.
- History of abnormal scarring such as Keloids.
Show all 13Show fewer
- History of vitiligo.
- Allergy or sensitivity or allergy to topical anesthesia
- Inability to use sunscreen.
- History of smoking in the last 10 years
- Scar or prior surgery in the area of treatment.
- Use of isotretinoin in the prior 6 months
- Subjects who have bleeding disorders or who are taking anticoagulants
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital Clinical Unit for Research Trials and Outcomes in Skin
Boston, Massachusetts, 02114
Molly Wanner, 617-726-5066, harvardskinstudies@partners.org
About this study
Official title: Impact of Chemical Peels and Fractional Laser on IGF-1 Levels in Skin
The purpose of this study is to evaluate the impact of fractional laser versus chemical peels on IGF-1 levels in skin.
Read the detailed description
This study is designed to assess the feasibility of using a fractional non ablative laser and chemical peels to wound skin, and thereby elicit a change in IGF-1. Our hypothesis is that fractional non ablative laser and a TCA chemical peel can induce similar effects as the fractional ablative laser at three months. In other words, our theory is that these approaches can stimulate the production of IGF-1 in older skin and restore UV damage repair and response mechanisms.
- Conditions
- Skin Cancer
- Being tested
- Fractional Laser and Chemical Peel
- Medical subject headings
- Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fractional Laser and Chemical PeelDevice
Fractional 1927 nm Laser, Fractional 1550 nm Laser, and 25% TCA (trichloroacetic acid) peel
| Study group | Role | What they receive |
|---|---|---|
| Fraxel 1927nm | Active comparator | Treatment setting for Fraxel 1927 nm: 20 mJ, Treatment level 8, 6 passes Receives: Device: Fractional Laser and Chemical Peel |
| Fraxel 1550nm | Active comparator | Treatment setting for Fraxel 1550 nm: 70 mJ, Treatment level 6, 6 passes Receives: Device: Fractional Laser and Chemical Peel |
| 25% TCA Peel | Active comparator | 25% TCA on 5 x 5 cm of sun exposed back Receives: Device: Fractional Laser and Chemical Peel |
| Control | Placebo comparator | Patient serves as their own control Receives: Device: Fractional Laser and Chemical Peel |
What is being measured
The primary outcome is the main question the study is designed to answer.
IGF-1 Levels
To quantify IGF-1 levels in skin
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2018
- Study start1 Dec 2019
- Primary completion1 Jul 2021 (estimated)
- Study completion1 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin CancerStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- Single group
- Model description
- Randomized-Controlled (Subjects will serve as their own control)
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Molly A. Wanner, MD, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03775031
- Sponsor's protocol ID
- 2018P001770
- Status last verified
- Oct 2020
- First submitted
- 12 Dec 2018
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- 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 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Chemical Peels and Fractional Laser on IGF-1 Levels in Skin
- ClinicalTrials.gov ID
- NCT03775031
- Acronym / sponsor ID
- 2018P001770
- Conditions
- Skin Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 1 Jul 2021 (estimated)
- Study completion
- 1 Jul 2021 (estimated)
- First posted
- 13 Dec 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.
The purpose of this study is to evaluate the impact of fractional laser versus chemical peels on IGF-1 levels in skin.
Detailed description
This study is designed to assess the feasibility of using a fractional non ablative laser and chemical peels to wound skin, and thereby elicit a change in IGF-1. Our hypothesis is that fractional non ablative laser and a TCA chemical peel can induce similar effects as the fractional ablative laser at three months. In other words, our theory is that these approaches can stimulate the production of IGF-1 in older skin and restore UV damage repair and response mechanisms.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Randomized-Controlled (Subjects will serve as their own control)
| Arm | Type | Receives |
|---|---|---|
| Fraxel 1927nm | Active comparator | Device: Fractional Laser and Chemical PeelTreatment setting for Fraxel 1927 nm: 20 mJ, Treatment level 8, 6 passes |
| Fraxel 1550nm | Active comparator | Device: Fractional Laser and Chemical PeelTreatment setting for Fraxel 1550 nm: 70 mJ, Treatment level 6, 6 passes |
| 25% TCA Peel | Active comparator | Device: Fractional Laser and Chemical Peel25% TCA on 5 x 5 cm of sun exposed back |
| Control | Placebo comparator | Device: Fractional Laser and Chemical PeelPatient serves as their own control |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female subjects >55 years old
- Fitzpatrick type I-II
- Able to provide informed consent.
- Cutaneous photodamage of 3 or above on the Larnier photodamage scale (see Appendix).
Key exclusion criteria (13 listed)
- Prior laser or peel treatment in the area evaluated in the current study in the past year.
- Currently taking immunosuppressant medications known to interfere wound healing or anti-inflammatory medications (such as NSAIDs, or steroids).
- Subjects who have underlying diseases that could alter wound healing response (such as Diabetes).
- Currently taking insulin.
- History of substance abuse, mental dysfunction, or other factors limiting ability to cooperate with study.
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 |
|---|---|---|
| Fractional Laser and Chemical PeelFractional 1927 nm Laser, Fractional 1550 nm Laser, and 25% TCA (trichloroacetic acid) peel | Device | 25% TCA Peel, Control, Fraxel 1550nm, Fraxel 1927nm |
Primary outcome
IGF-1 Levels
Time frame: 3 months
To quantify IGF-1 levels in skin
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 22 Oct 2020.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fractional Laser and Chemical Peel in people with Skin Cancer, run by Massachusetts General Hospital at 1 site in United States.
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 13 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 22 Oct 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 United States. 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. Some participants in this study may receive a placebo. 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 Molly Wanner, MD (617-726-5066, mwanner@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IGF-1 Levels (time frame: 3 months). 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 22 Oct 2020.