Evaluation of the Safety and Efficacy of the DeScribe™ Patch
16. september 2016 opdateret af: ON Light Sciences
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.
Studieoversigt
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
30
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Tennessee
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Nashville, Tennessee, Forenede Stater, 37203
- Nashville Centre for Laser and Facial Surgery
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 90 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: DeScribe patch
Comparison of the number of passes achieved using the Describe patch plus laser compared to laser along
|
Application of Describe patch over tattoo for approximately 5 minutes during Q-switched laser treatment
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of passes with Describe patch
Tidsramme: 5 minutes
|
Number of passes with Describe patch compared to laser only
|
5 minutes
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Safety assessment: Overall rate and severity of all reported adverse events
Tidsramme: immediate post treatment, 1-month post tx
|
Overall rate and severity of all reported adverse events
|
immediate post treatment, 1-month post tx
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Brian Biesman, MD, Nashville Centre for Laser and Facial Surgery
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. november 2014
Primær færdiggørelse (Faktiske)
1. januar 2015
Studieafslutning (Faktiske)
1. april 2015
Datoer for studieregistrering
Først indsendt
13. november 2014
Først indsendt, der opfyldte QC-kriterier
20. november 2014
Først opslået (Skøn)
21. november 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
20. september 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
16. september 2016
Sidst verificeret
1. september 2016
Mere information
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .