TattoosNCT02297321
Evaluation of the Safety and Efficacy of the DeScribe™ Patch
A study testing Describe patch in people with Tattoos, run by ON Light Sciences at 1 site in United States.
Trial summary
This is a prospective study to evaluate the efficacy and safety of an accessory for laser tattoo removal in allowing multiple passes within a single treatment session. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Tattoos
- What is being tested?
- Describe patch
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Apr 2015
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects presenting with tattoos approximately 2 ½" x 6" or 3" x 5" or smaller in size.
- Fitzpatrick skin type I - III
- Women of childbearing potential using an accepted form of contraception at least 3 months prior to enrollment and during the study period (i.e., oral contraceptives, IUD, contraceptive implant, barrier methods with spermicide, or abstinence)
- Subjects who provide written informed consent
- Subjects who agree to all treatment guidelines and follow-up visits
Who cannot join
- Subjects younger than 18 years of age
- Subjects with traumatic tattoos
- As per the investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in the study
- Subjects who are pregnant or breastfeeding
- Subjects who are tan
- As per the investigator's discretion, subjects with a history of keloid scarring or abnormal wound healing
Show all 9Show fewer
- Subjects who have used oral retinoids (isotretinoin or acitretin) within 12 months of study entry
- Subjects currently participating or planning to participate in any other clinical trial specifically designed to treat tattoos during the course of this study and for the duration of their participation in the study
- Subjects who refuse to sign this informed consent form and/or refuse to comply with all study requirements.
Trial locations and contacts
1 site in 1 country.
United States1 site
Nashville Centre for Laser and Facial Surgery
Nashville, Tennessee, 37203
About this study
Official title: Evaluation of the Safety and Efficacy of the DeScribe™ Laser Tattoo Removal Accessory Device
This is a prospective study to evaluate the efficacy and safety of an accessory for laser tattoo removal in allowing multiple passes within a single treatment session.
Read the detailed description
This is a prospective study to evaluate the efficacy and safety of an accessory for laser tattoo removal in allowing multiple passes within a single treatment session. One half of the tattoo will be randomly assigned laser treatment utilizing the Device (the "Device half"); the other half will receive laser treatment without the Device and serve as the control (the "Control half"). Based on statistical analysis sample size calculations, 30 subjects will be enrolled. The tattoo must be no larger than approximately 2 ½" x 6" or 3" x 5" in size, such that ½ of the tattoo can be covered with a single patch. Each subject will receive a single Treatment Session consisting of 5 minutes. Investigators will administer the standard laser treatment to both the Device and Control sites using well-established tattoo-removal treatment parameters for the laser used. Subjects will return for follow up approximately one month post-treatment. The presence of side effects and adverse events will be assessed and recorded for both Device and Control sites immediately after treatment and at the 1-month follow-up visit.
- Conditions
- Tattoos
- Being tested
- Describe patch
- Keywords
- tattoos, laser, whitening, patch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Describe patchDevice
Application of Describe patch over tattoo for approximately 5 minutes during Q-switched laser treatment
| Study group | Role | What they receive |
|---|---|---|
| DeScribe patch | Experimental | Comparison of the number of passes achieved using the Describe patch plus laser compared to laser along Receives: Device: Describe patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of passes with Describe patch
Number of passes with Describe patch compared to laser only
Measured: 5 minutes
Secondary outcomes (1)
Safety assessment: Overall rate and severity of all reported adverse events
Overall rate and severity of all reported adverse events
Measured: immediate post treatment, 1-month post tx
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionJan 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TattoosStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- ON Light Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Brian Biesman, MD, Principal investigator, Nashville Centre for Laser and Facial Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02297321
- Sponsor's protocol ID
- DeScribe-01
- Status last verified
- Sep 2016
- First submitted
- 13 Nov 2014
- Last updated
- 20 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Efficacy of the DeScribe™ Laser Tattoo Removal Accessory Device
- ClinicalTrials.gov ID
- NCT02297321
- Acronym / sponsor ID
- DeScribe-01
- Conditions
- Tattoos
- Keywords
- tattoos, laser, whitening, patch
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- ON Light SciencesIndustry (pharma, biotech, devices)
- Study start
- Nov 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 21 Nov 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.
This is a prospective study to evaluate the efficacy and safety of an accessory for laser tattoo removal in allowing multiple passes within a single treatment session.
Detailed description
This is a prospective study to evaluate the efficacy and safety of an accessory for laser tattoo removal in allowing multiple passes within a single treatment session. One half of the tattoo will be randomly assigned laser treatment utilizing the Device (the "Device half"); the other half will receive laser treatment without the Device and serve as the control (the "Control half"). Based on statistical analysis sample size calculations, 30 subjects will be enrolled. The tattoo must be no larger than approximately 2 ½" x 6" or 3" x 5" in size, such that ½ of the tattoo can be covered with a single patch. Each subject will receive a single Treatment Session consisting of 5 minutes. Investigators will administer the standard laser treatment to both the Device and Control sites using well-established tattoo-removal treatment parameters for the laser used. Subjects will return for follow up approximately one month post-treatment. The presence of side effects and adverse events will be assessed and recorded for both Device and Control sites immediately after treatment and at the 1-month follow-up visit.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DeScribe patch | Experimental | Device: Describe patchComparison of the number of passes achieved using the Describe patch plus laser compared to laser along |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects presenting with tattoos approximately 2 ½" x 6" or 3" x 5" or smaller in size.
- Fitzpatrick skin type I - III
- Women of childbearing potential using an accepted form of contraception at least 3 months prior to enrollment and during the study period (i.e., oral contraceptives, IUD, contraceptive implant, barrier methods with spermicide, or abstinence)
- Subjects who provide written informed consent
- Subjects who agree to all treatment guidelines and follow-up visits
Key exclusion criteria (9 listed)
- Subjects younger than 18 years of age
- Subjects with traumatic tattoos
- As per the investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in the study
- Subjects who are pregnant or breastfeeding
- Subjects who are tan
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 |
|---|---|---|
| Describe patchApplication of Describe patch over tattoo for approximately 5 minutes during Q-switched laser treatment | Device | DeScribe patch |
Primary outcome
Number of passes with Describe patch
Time frame: 5 minutes
Number of passes with Describe patch compared to laser only
1 secondary outcome
Safety assessment: Overall rate and severity of all reported adverse events
Time frame: immediate post treatment, 1-month post tx
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 20 Sep 2016.
- Individual participant dataSharing planned: No
Related trials for Tattoos
Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
Hair Reduction, Tattoo Removal
Not yet recruiting
Evaluation of Automated Laser-Assisted Tattoo Removal: a Prospective Feasibility Clinical Study
Persons Seeking Tattoo Removal
Recruiting
Tumor Margin Skin Tattooing Before Neo-adjuvant Chemotherapy in Patients With Breast Cancer
Breast Cancer (Locally Advanced or Metastatic), Tattoo Skin Markers
Not yet recruitingObservational study
The Impact of Having a Tattoo on Fertility Treatment Outcome
Infertility, Assisted Reproductive Technology Outcomes
Enrolling by invitation
Confirming the Accuracy of Endoscopic Marking Using a New Marker, a Novel Luminomarker, in Lesion Marking Before Colorectal Cancer Surgery.
Colorectal Cancer, Endoscopic Tattoo of Suspected Colon Cancer
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.
Brian Biesman, MD principal investigator
Nashville Centre for Laser and Facial Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Describe patch in people with Tattoos, run by ON Light Sciences 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 5 inclusion and 9 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 20 Sep 2016. 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?
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?
Number of passes with Describe patch (time frame: 5 minutes). 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 20 Sep 2016.