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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cynosure, Inc.
ClinicalTrials.gov Identifier:
NCT01745224
First received: December 6, 2012
Last updated: February 7, 2014
Last verified: February 2014
  Purpose

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


Condition Intervention
Melasma
Device: Revlite Q switched Nd:YAG
Device: Trivantage Q switched Nd: YAG

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Further study details as provided by Cynosure, Inc.:

Primary Outcome Measures:
  • Live assessment of aesthetic level of improvement using Global Aesthetic Improvement Scale by PI at 1 and 3 months [ Time Frame: up to 3 months post last treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assessment of subject tolerability during and immediate post treatment using Universal Pain Scale [ Time Frame: up to 3 months post last treatment ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Assessment of PI and Subject satisfaction with the treatment outcomes per Questionnaire at 1 and 3 months [ Time Frame: up to 3 months post last treatment ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: July 2012
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01745224

Locations
United States, New York
NY Laser and Skin Care
New York, New York, United States, 10028
Sponsors and Collaborators
Cynosure, Inc.
Investigators
Study Director: Patricia Krantz Cynosure, Inc.
  More Information

No publications provided

Responsible Party: Cynosure, Inc.
ClinicalTrials.gov Identifier: NCT01745224     History of Changes
Other Study ID Numbers: CYN12-REV-TRI-AK
Study First Received: December 6, 2012
Last Updated: February 7, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on October 21, 2014