Skin Type From I-VI on Non-hair Bearing SkinNCT02130609
Skintel Integration Study
A study testing Skintel in people with Skin Type From I-VI on Non-hair Bearing Skin, run by Cynosure, Inc..
Trial summary
The objective of this study is to improve the treatment guidelines for the Elite+ by determining the maximum safe settings for skin and correlate them to measurement of Melanin Index (MI) (MI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skin Type From I-VI on Non-hair Bearing Skin
- What is being tested?
- Skintel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- Dec 2013to Sep 2016
- Phase
- Interventional
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years and older
- Able to read, understand, and sign the Informed Consent Form
- Willing and able to comply with all study requirements
Who cannot join
- Hypersensitivity to light in the near infrared wavelength region
- Sun-damaged skin (treatment contraindicated with Alex laser only)
- Unprotected sun exposure (for Alex laser within four weeks of treatment; for
- Nd:YAG laser within one week of treatment), including the use of tanning beds or
- tanning products, such as creams, lotions and sprays
- Take medication which is known to increase sensitivity to sunlight
Show all 17Show fewer
- Seizure disorders triggered by light
- Take anticoagulants
- Take or have taken oral isotretinoin, such as Accutane®, within the last six months
- Take medication that alters the wound-healing response
- History of healing problems or history of keloid formation
- Active localized or systemic infection, or an open wound in area being treated
- Significant systemic illness or an illness localized in area being treated
- History of skin cancer or suspicious lesions
- Lupus
- Have received or are receiving or gold therapy
- Pregnancy, planning on becoming pregnant or have been pregnant recently
About this study
Official title: Skintel Integration Study for Use With the Elite+ Laser System
The objective of this study is to improve the treatment guidelines for the Elite+ by determining the maximum safe settings for skin and correlate them to measurement of Melanin Index (MI) (MI).
- Being tested
- Skintel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SkintelDevice
| Study group | Role | What they receive |
|---|---|---|
| Skintel | Experimental | Not described Receives: Device: Skintel |
What is being measured
The primary outcome is the main question the study is designed to answer.
improve the treatment guidelines for the Elite+ by determining the maximum safe settings for skin and correlate them to measurement of Melanin Index
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2014 (estimated)
- Study startDec 2013
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin Type From I-VI on Non-hair Bearing 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 N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Even though this study has recruited more than 10 participants, it is a feasibility study, designed to test the prototype rather than measuring health outcomes. It is to confirm the operating specifications before beginning a full clinical trial. The objective of this study is to improve the treatment guidelines for the Elite+ by determining the maximum safe settings for skin and correlate them to measurement of Melanin Index (MI).
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cynosure, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sean Doherty, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02130609
- Sponsor's protocol ID
- CYN13-SkinTel-Elite+-01
- Status last verified
- Oct 2020
- First submitted
- 1 May 2014
- Last updated
- 28 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skintel Integration Study for Use With the Elite+ Laser System
- ClinicalTrials.gov ID
- NCT02130609
- Acronym / sponsor ID
- CYN13-SkinTel-Elite+-01
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Cynosure, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 5 May 2014 (estimated)
- 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 objective of this study is to improve the treatment guidelines for the Elite+ by determining the maximum safe settings for skin and correlate them to measurement of Melanin Index (MI) (MI).
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Even though this study has recruited more than 10 participants, it is a feasibility study, designed to test the prototype rather than measuring health outcomes. It is to confirm the operating specifications before beginning a full clinical trial. The objective of this study is to improve the treatment guidelines for the Elite+ by determining the maximum safe settings for skin and correlate them to measurement of Melanin Index (MI).
| Arm | Type | Receives |
|---|---|---|
| Skintel | Experimental | Device: Skintel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years and older
- Able to read, understand, and sign the Informed Consent Form
- Willing and able to comply with all study requirements
Key exclusion criteria (17 listed)
- Hypersensitivity to light in the near infrared wavelength region
- Sun-damaged skin (treatment contraindicated with Alex laser only)
- Unprotected sun exposure (for Alex laser within four weeks of treatment; for
- Nd:YAG laser within one week of treatment), including the use of tanning beds or
- tanning products, such as creams, lotions and sprays
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 |
|---|---|---|
| Skintel | Device | Skintel |
Primary outcome
improve the treatment guidelines for the Elite+ by determining the maximum safe settings for skin and correlate them to measurement of Melanin Index
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2020.
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.
Sean Doherty, MD principal investigator
Questions about this trial
What is this clinical trial studying?
A study testing Skintel in people with Skin Type From I-VI on Non-hair Bearing Skin, run by Cynosure, Inc..
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 3 inclusion and 17 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 28 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
improve the treatment guidelines for the Elite+ by determining the maximum safe settings for skin and correlate them to measurement of Melanin Index (time frame: 9 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 28 Oct 2020.