Pre-cancerous Geriatric SkinLaser GenesisNCT02090894
Effect of Dermal Rejuvenation on the UVB Response of Geriatric Skin
A study testing UV Light (Laser Genesis) in people with Pre-cancerous Geriatric Skin, run by Indiana University at 1 site in United States.
Trial summary
The objective of this study is to examine the ability of dermal rejuvenation therapies to protect geriatric skin from ultraviolet light (UVB)-induced carcinogenesis. Skin cancers (including basal cell carcinoma and squamous cell carcinoma) are the most common types of malignancy and are related to UVB exposure in… Read more about this study
- Who is it for?
- Ages 65 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Pre-cancerous Geriatric Skin
- What is being tested?
- UV Light (Laser Genesis)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Dec 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 to 99 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Only subjects older than 65 years will be enrolled.
- Subject's skin type must be "Fair", Fitzpatrick type I or II.
Who cannot join
- Subjects who have underlying diseases that could affect wound healing (eg, diabetes mellitus)
- on medications that are known photosensitizers,
- or have a history of abnormal scarring (eg, keloids) will be excluded.
- Subjects will be asked the screening questions below as part of the inclusion/exclusion criteria
- How old are you?
- Do you regularly use tanning beds?
Show all 12Show fewer
- Are you being treated with light therapy?
- Have you had any diseases that got worse when you went in the sun?
- Are you taking any medications that warn you to stay out of the sun?
- Have you ever had a reaction to medications that were applied to your skin?
- When cuts or wounds on your skin heal, are the scars abnormally large or take a long time to heal?
- Do you have diabetes mellitus or have you ever had high blood sugar?
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Department of Dermatology
Indianapolis, Indiana, 46202
About this study
The objective of this study is to examine the ability of dermal rejuvenation therapies to protect geriatric skin from ultraviolet light (UVB)-induced carcinogenesis. Skin cancers (including basal cell carcinoma and squamous cell carcinoma) are the most common types of malignancy and are related to UVB exposure in sunlight. UVB-irradiation of skin causes specific DNA damage to keratinocytes that can lead to cancer-causing mutations if they are allowed to persist in proliferating cells. Moreover, the incidence of skin cancers is much greater in elderly over younger individuals. The objective of the present study is to build upon our previous data and test the effect of a non ablative Nd:YAG laser (LaserGenesis) of a localized area of skin on dermal IGF-1 production and UVB-mediated keratinocyte effects. Treatment of skin using a non ablative high-peak power microsecond pulsed 1064 nm Nd:YAG laser (Cutera's LaserGenesisTM laser) leads to papillary dermal heating. The laser targets the microvasculature and stimulates collagen production while protecting the epidermis. Generally, Laser Genesis is used clinically to improve irregularities in the contour, texture, and color of the skin. Laser Genesis is also used to help treat photoaging by increasing collagen formation, suggesting that it stimulates fibroblast activity and thus possibly increases levels of protective IGF-1.
- Conditions
- Pre-cancerous Geriatric Skin
- Being tested
- UV Light (Laser Genesis)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UV Light (Laser Genesis)Device
| Study group | Role | What they receive |
|---|---|---|
| UV Light | Experimental | Not described Receives: Device: UV Light (Laser Genesis) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Basal Layer Keratinocytes Positive for Both Ki67 and Thymine Dimers
Number of double positive cells per 1000 total basal layer keratinocytes
Measured: untreated and LaserGenesis treated, three months after treatment, 24 hours after 350 J/m2 of UVB
Secondary outcomes (1)
Relative Level of IGF-1 mRNA in the Skin
IGF-1 mRNA per 100,000 beta-2 microglobulin mRNA. Beta-2 microglobulin mRNA was used as a reference gene for this assessment and that the data represent number of copies IGF-1/100,000 copies b2-microglobulin.
Measured: untreated and LaserGenesis treated, three months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2014 (estimated)
- Study startMar 2011
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pre-cancerous Geriatric SkinStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ally-Khan Somani, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02090894
- Sponsor's protocol ID
- 1105005442
- Acronym
- Laser Genesis
- Status last verified
- May 2018
- First submitted
- 28 Jan 2014
- Last updated
- 11 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dermal Rejuvenation on the UVB Response of Geriatric Skin
- ClinicalTrials.gov ID
- NCT02090894
- Acronym / sponsor ID
- Laser Genesis / 1105005442
- Conditions
- Pre-cancerous Geriatric Skin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 18 Mar 2014 (estimated)
- Results
- Posted 2 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to examine the ability of dermal rejuvenation therapies to protect geriatric skin from ultraviolet light (UVB)-induced carcinogenesis. Skin cancers (including basal cell carcinoma and squamous cell carcinoma) are the most common types of malignancy and are related to UVB exposure in sunlight. UVB-irradiation of skin causes specific DNA damage to keratinocytes that can lead to cancer-causing mutations if they are allowed to persist in proliferating cells. Moreover, the incidence of skin cancers is much greater in elderly over younger individuals. The objective of the present study is to build upon our previous data and test the effect of a non ablative Nd:YAG laser (LaserGenesis) of a localized area of skin on dermal IGF-1 production and UVB-mediated keratinocyte effects. Treatment of skin using a non ablative high-peak power microsecond pulsed 1064 nm Nd:YAG laser (Cutera's LaserGenesisTM laser) leads to papillary dermal heating. The laser targets the microvasculature and stimulates collagen production while protecting the epidermis. Generally, Laser Genesis is used clinically to improve irregularities in the contour, texture, and color of the skin. Laser Genesis is also used to help treat photoaging by increasing collagen formation, suggesting that it stimulates fibroblast activity and thus possibly increases levels of protective IGF-1.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| UV Light | Experimental | Device: UV Light (Laser Genesis) |
Who may qualify
- Ages
- 65 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Only subjects older than 65 years will be enrolled.
- Subject's skin type must be "Fair", Fitzpatrick type I or II.
Key exclusion criteria (12 listed)
- Subjects who have underlying diseases that could affect wound healing (eg, diabetes mellitus)
- on medications that are known photosensitizers,
- or have a history of abnormal scarring (eg, keloids) will be excluded.
- Subjects will be asked the screening questions below as part of the inclusion/exclusion criteria
- How old are you?
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 |
|---|---|---|
| UV Light (Laser Genesis) | Device | UV Light |
Primary outcome
Difference in Basal Layer Keratinocytes Positive for Both Ki67 and Thymine Dimers
Time frame: untreated and LaserGenesis treated, three months after treatment, 24 hours after 350 J/m2 of UVB
Number of double positive cells per 1000 total basal layer keratinocytes
1 secondary outcome
Relative Level of IGF-1 mRNA in the Skin
Time frame: untreated and LaserGenesis treated, three months after treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UV Light (Laser Genesis) in people with Pre-cancerous Geriatric Skin, run by Indiana University 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 2 inclusion and 12 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: finished, as of the sponsor's last update on 11 Oct 2018. 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. 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?
Yes. Results are posted in the registry (first posted 2 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Difference in Basal Layer Keratinocytes Positive for Both Ki67 and Thymine Dimers (time frame: untreated and LaserGenesis treated, three months after treatment, 24 hours after 350 J/m2 of UVB). 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 11 Oct 2018.