NCT03866304

Brief Summary

Evaluate safety and efficacy of S2 multi-wavelength laser for tattoo removal

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 21, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 27, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 7, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2019

Completed
Last Updated

March 7, 2019

Status Verified

March 1, 2019

Enrollment Period

7 months

First QC Date

February 27, 2019

Last Update Submit

March 6, 2019

Conditions

Tattoo Removal

Outcome Measures

Primary Outcomes (1)

  • Tattoo clearing

    Tattoo clearing as rated by blinded reviewers at 8 weeks post-final treatment (Physician's Global Assessment of Improvement). Blinded reviewer will first be asked to determine the temporal order (before and after) of each photograph pair for each treatment side and then rate the degree of tattoo clearing observed in the after photograph (compared to before photograph) using the Physician's Global Assessment scale: 4 = Very Significant Clearing (\> 75%) 3 = Significant Clearing (51 - 75%) 2 = Moderate Clearing (26 - 50%) 1 = Mild Clearing (5 - 25%) 0 = No Change (\< 5%)

    8 weeks post-final treatment (up to 6 month)

Secondary Outcomes (4)

  • Degree of tattoo clearing as assessed by PGA

    8 weeks post-final treatment (up to 6 month)

  • Degree of tattoo clearing at 8 weeks post-final treatment as assessed by Subject

    8 weeks post-final treatment (up to 6 month)

  • Subject discomfort (pain) during treatments

    During the treatments period (up to 6 month)

  • Subject satisfaction Questionnaire (4-8 weeks post-final treatment)

    4-8 weeks post-final treatment (up to 6 month)

Study Arms (1)

Picosecond Laser

EXPERIMENTAL

Treatment with investigational wavelengths of the S2 laser for tattoo removal.

Device: Device: S2 Picosecond laser

Interventions

Device: S2 Picosecond laserDEVICE

Each subject will receive up to 16 laser treatments.

Picosecond Laser

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy female and male subjects between 18 to 65 years of age
  • Fitzpatrick Skin Type I - VI
  • Have unwanted decorative (non-cosmetic) tattoo(s) and willing to undergo laser treatments to remove them
  • Have a tattoo contains containing single or multi-color ink.
  • Willing to receive the proposed S2 laser treatments and comply with study (protocol) requirements
  • Must be able to read, understand and sign the Informed Consent Form
  • Must be willing and able to adhere to the treatment and follow-up schedule and post-treatment care instructions.
  • Agree not to undergo any other procedure(s) for the tattoo removal during the study.

You may not qualify if:

  • Participation in a study of another device or drug within 6 months prior to enrollment or during the study.
  • Pregnant or planning to become pregnant, having given birth less than 3 months prior to treatment, and/or breastfeeding
  • History of allergic reaction to pigments following tattooing.
  • History of hypersensitivity to light exposure
  • Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study.
  • History of malignant tumors in the target area.
  • Suffering from significant skin conditions in the treated areas or inflammatory skin conditions, including, but not limited to, open lacerations or abrasions, hidradenitis, or dermatitis of the treatment area prior to treatment or during the treatment course
  • Anytime in life, having have used gold therapy (gold salts) for disorders such as rheumatologic disease or lupus.
  • History of keloid scarring, abnormal wound healing and / or prone bruising
  • Significant concurrent illness, such as diabetes mellitus or cardiovascular disease, e.g., uncontrolled hypertension.
  • Suffering from coagulation disorders or taking prescription anticoagulation medications.
  • History of keloid scarring, hypertrophic scarring or of abnormal wound healing.
  • History of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications.
  • History of vitiligo, eczema, or psoriasis.
  • History of connective tissue disease, such as systemic lupus erythematosus or scleroderma.
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Santara KTC (clinical trial site)

Vilnius, 08406, Lithuania

RECRUITING

Study Officials

  • Ruta Ganceviciene,, Dr

    Santara KTC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Linas Leikis, Dr

CONTACT

(+370) 612 25255linas.liekis@inlita.lt

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2019

First Posted

March 7, 2019

Study Start

January 21, 2019

Primary Completion

August 31, 2019

Study Completion

August 31, 2019

Last Updated

March 7, 2019

Record last verified: 2019-03

Locations

LI(1)