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

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ClinicalTrials.gov Identifier: NCT01745224
Recruitment Status : Completed
First Posted : December 10, 2012
Last Update Posted : February 10, 2014
Sponsor:
Information provided by (Responsible Party):
Cynosure, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Melasma Device: Revlite Q switched Nd:YAG Device: Trivantage Q switched Nd: YAG Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : July 2012
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

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




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Assessment of subject tolerability during and immediate post treatment using Universal Pain Scale [ Time Frame: up to 3 months post last treatment ]

Other Outcome Measures:
  1. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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.

Responsible Party: Cynosure, Inc.
ClinicalTrials.gov Identifier: NCT01745224     History of Changes
Other Study ID Numbers: CYN12-REV-TRI-AK
First Posted: December 10, 2012    Key Record Dates
Last Update Posted: February 10, 2014
Last Verified: February 2014

Additional relevant MeSH terms:
Melanosis
Hyperpigmentation
Pigmentation Disorders
Skin Diseases