Revlite Laser System Compared to the Candela Alex TriVantage System Refractory Mixed Type Melasma
This study is currently recruiting participants.
Verified March 2013 by Cynosure, Inc.
Sponsor:
Cynosure, Inc.
Information provided by (Responsible Party):
Cynosure, Inc.
ClinicalTrials.gov Identifier:
NCT01745224
First received: December 6, 2012
Last updated: March 20, 2013
Last verified: March 2013
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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 ]
| Estimated Enrollment: | 10 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | July 2013 |
| Estimated 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:
- Subjects with Fitzpatrick Skin Type III-VI
- Subjects with mixed (epidermal and dermal) type melasma diagnosed by Wood's Lamp.
- Subjects who are over the age of 18 years of age
- The subject is willing and able to comply with study instructions and return to the clinic for required visits.
- 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:
- 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.
- The subject has a history of cutaneous photosensitization, porphyria, and hypersensitivity to porphyrins or photodermatosis.
- The subject has any skin pathology or condition that could interfere with the evaluation or requires the use of interfering topical or systemic therapy.
- The subject has an uncorrected coagulation defect or is currently using anti-coagulation medication (including but not limited to heavy aspirin therapy).
- The subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.
- 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.
- 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.
- The subject has the need to be exposed to artificial tanning devices or excessive sunlight during the trial.
- The subject has had prior treatment with parenteral gold therapy (gold sodium thiomalate).
- The subject has Diabetes Type 1 or 2.
- The subject has a sensitivity to hydroquinone or Retin-A.
- The subject has evidence of a compromised immune system or hepatitis.
- 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.
- Has a history of keloids or hypertrophic scarring
- Has permanent make-up and/or is unwilling to refrain from using semi-permanent cosmetics during study
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01745224
Contacts
| Contact: Kauvar Nurses | 212-249-9440 |
Locations
| United States, New York | |
| NY Laser and Skin Care | Recruiting |
| New York, New York, United States, 10028 | |
| Contact 212-249-9440 | |
| Principal Investigator: Arielle Kauvar, M.D. | |
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: | March 20, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Melanosis Hyperpigmentation Pigmentation Disorders Skin Diseases |
ClinicalTrials.gov processed this record on May 16, 2013