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N/A Completed N=10 Randomized Device Feasibility

Study for the RevLite Laser System for Facial Solar Lentigines

Facial Solar Lentigines
Source: ClinicalTrials.gov NCT02110108 ↗
Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcomePrimary: Photographic Evaluation Using the Blinded Global Aesthetic Improvement Scale — 0; 1; 3; 3 Participants

Summary

The purpose of this study is to evaluate the effects of the Revlite Laser System for treatment of facial solar lentigines

Outcome Measures

OutcomeResultp-value
PRIMARY
Photographic Evaluation Using the Blinded Global Aesthetic Improvement Scale
0; 1; 3; 3; 6; 4
SECONDARY
Physician Satisfaction Questionnaire
3.70; 3.600

Eligibility Criteria

Inclusion Criteria

  • Is a healthy male or female between 18 and 60 years old.
  • Is Fitzpatrick Skin types I-III
  • Is willing to consent to participate in the study.
  • Is willing to comply with all requirements of the study including being photographed, following post treatment care and attending all treatment and follow up visits.
  • Has clinically determined mild to severe facial mottled pigmentation (solar lentigines) on the face.

Exclusion Criteria

  • Is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period.
  • Is hypersensitive to light exposure OR takes photo sensitized medication.
  • Has active or localized systemic infections.
  • Has a coagulation disorder or is currently using anti-coagulation medication (including but not limited to the heavy use of aspirin {greater than 81 mg per day}).
  • Has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.
  • Is currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within 3 months prior to entering this study.
  • Has used Accutane within 6 months prior to enrollment.
  • Has the need to be exposed to artificial tanning devices or excessive sunlight during the trial.
  • Has had prior treatment with parenteral gold therapy (gold sodium thiomalate).
  • Has a history of keloids.
  • Has evidence of compromised wound healing.
  • Has a history of basal cell carcinoma, squamous cell carcinoma or melanoma.
  • Has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications or has an autoimmune disorder.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02110108). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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