Revlite Laser System Compared to the Candela Alex TriVantage System Refractory Mixed Type Melasma

This proof of concept study will be conducted to assess the aesthetic improvement in refractory mixed type melasma in subjects treated with two FDA 510K approved devices: Q Switched Nd: YAG Laser vs. Alex TriVantage

Study Overview

• Status: Terminated
• Conditions: Melasma
• Intervention / Treatment: Device: Revlite Q switched Nd:YAG; Device: Trivantage Q switched Nd: YAG

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10028
      • NY Laser and Skin Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Subjects with Fitzpatrick Skin Type III-VI
2. Subjects with mixed (epidermal and dermal) type melasma diagnosed by Wood's Lamp.
3. Subjects who are over the age of 18 years of age
4. The subject is willing and able to comply with study instructions and return to the clinic for required visits.
5. The subject's melasma has persisted for greater than 6 months and has failed to respond to conventional treatment with hydroquinone cream or other topical lightening agents.

Exclusion Criteria:

1. The subject is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period.
2. The subject has a history of cutaneous photosensitization, porphyria, and hypersensitivity to porphyrins or photodermatosis.
3. The subject has any skin pathology or condition that could interfere with the evaluation or requires the use of interfering topical or systemic therapy.
4. The subject has an uncorrected coagulation defect or is currently using anti-coagulation medication (including but not limited to heavy aspirin therapy).
5. The subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.
6. The subject is currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within 30 days prior to entering this study.
7. The subject has used photosensitizing drugs (e.g., Declomycin, sulfa antibiotics, phenothiazines, etc.) within a timeframe where photosensitization from these drugs may still be present.
8. The subject has the need to be exposed to artificial tanning devices or excessive sunlight during the trial.
9. The subject has had prior treatment with parenteral gold therapy (gold sodium thiomalate).
10. The subject has Diabetes Type 1 or 2.
11. The subject has a sensitivity to hydroquinone or Retin-A.
12. The subject has evidence of a compromised immune system or hepatitis.
13. Has had microdermabrasion in past 3 months, other laser or Intense Pulsed Light treatment or chemical peels to the face in past 6 months, injectable fillers, topical retinoids, over-the-counter anti-aging products past 2 weeks.
14. Has a history of keloids or hypertrophic scarring
15. Has permanent make-up and/or is unwilling to refrain from using semi-permanent cosmetics during study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Revlite Q switched Nd:YAG laser; Revlite Q switched Nd:YAG laser 1064 nm	Device: Revlite Q switched Nd:YAG; Revlite Q switched Nd:YAG 1064nm; Device: Trivantage Q switched Nd: YAG; Trivantage Q switched Nd: YAG 1064nm
Experimental: TriVantage Q switched Nd:YAG laser; TriVantage Q switched Nd:YAG laser 1064nm	Device: Revlite Q switched Nd:YAG; Revlite Q switched Nd:YAG 1064nm; Device: Trivantage Q switched Nd: YAG; Trivantage Q switched Nd: YAG 1064nm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Melasma Determined by Physician	The Global Aesthetic Improvement scale was used to determine the amount of improvement. This scale ranges from 1 to 5, where 1 is very much improved, 2 is much improved, 3 is improved, 4 is no change, and 5 is worsened.	3 months post last treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Universal Pain Scale for Subject Tolerability	The subject pain tolerability was assessed using the Universal Pain Scale. This scale ranges from 0 (no pain) to 10 (worst pain possible).	3 months post last treatment

Collaborators and Investigators

• Sponsor: Cynosure, Inc.

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: December 6, 2012
• First Submitted That Met QC Criteria: December 6, 2012
• First Posted (Estimate): December 10, 2012

Study Record Updates

• Last Update Posted (Actual): December 4, 2020
• Last Update Submitted That Met QC Criteria: December 3, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Hyperpigmentation; Pigmentation Disorders; Melanosis
• Other Study ID Numbers: CYN12-REV-TRI-AK