Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02110134
Other study ID # CYN13-REV-TOP-MEL-AK
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 2013
Est. completion date May 2014

Study information

Verified date November 2020
Source Cynosure, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to compare a hydroquinone skin care regimen alone to a combination of Revlite Laser treatment with a hydroquinone skin care regimen for the treatment of melasma.


Recruitment information / eligibility

Status Completed
Enrollment 6
Est. completion date May 2014
Est. primary completion date May 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Revlite Laser System with hydroquinone skin care regimen
Revlite Laser System with hydroquinone skin care regimen for the Treatment of Melasma
Other:
Hydroquinone skin care regimen
Hydroquinone skin care regimen for the Treatment of Melasma

Locations

Country Name City State
United States NY Laser and Skin Care New York New York

Sponsors (1)

Lead Sponsor Collaborator
Cynosure, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rates of Adverse Events Among Patients Adverse events were collected and reported to test the safety and efficacy of the device. From study baseline to completion, approximately 1 year. However, adverse events not resolved by then will be followed up with until they are resolved.
Secondary Satisfaction Questionnaire Physician and subject satisfaction will be ranked on a scale from 1 to 5, where 1 is extremely dissatisfied and 6 is extremely satisfied. 1 month post last treatment
Secondary Photographic Evaluation using the Global Aesthetic Improvement Scale Photos will be a taken at baseline and post treatment and then improvement assessed using the Global Aesthetic Improvement Scale. This scale ranges from 0 to 3, where 0 is 0-25% clearance from baseline photograph, 1 is 25-50% clearance from baseline photograph, 2 is 50-75% clearance from baseline photograph, and 3 is 75-100% clearance from baseline photograph. 1 month post last treatment
See also
  Status Clinical Trial Phase
Completed NCT05013801 - A Clinical Study to Evaluate the Effect of Facial Serum Q69 in Moderating the Appearance of Mild to Moderate Melasma N/A
Recruiting NCT06174545 - Effectiveness and Safety of Pigment Solution Program (PSP) as Adjuvant Therapy in Melasma N/A
Completed NCT01695356 - Ultraviolet and UV-Visible Light Photoprotection for the Treatment of Melasma Phase 4
Recruiting NCT06278948 - Efficacy and Tolerability of Test Product Versus Cysteamine 5% in Treatment of Facial Epidermal Melasma N/A
Not yet recruiting NCT05911698 - Fractional co2 Laser Followed by Either Vitamin c or Tranexamic Acid in Treatment of Melasma. N/A
Recruiting NCT05656833 - Combination Topical Cysteamine and Fractional 1927nm Low-Powered Diode Laser for Treatment of Facial Melasma N/A
Recruiting NCT04597203 - Efficacy and Safety of Using Combination of 755-nm Picosecond Alexandrite Laser and 2% Hydroquinone Compared With 2% Hydroquinone Alone for the Treatment of Melasma: a Randomized Split-face Controlled Trial N/A
Completed NCT02138539 - Evaluation of an Herbal-Based De-Pigmenting System Phase 4
Recruiting NCT01661556 - Clinical Trial of Hydroquinone Versus Miconazol in Melasma Phase 4
Completed NCT01001624 - Melanil in the Treatment of Melasma Phase 3
Terminated NCT03415685 - Lutronic PicoPlus Exploratory Clinical Trial N/A
Recruiting NCT04765930 - Combined Q-switched Nd:YAG Laser and Platelet Rich Plasma Versus Q- Switched Nd:YAG Laser Alone in Melasma N/A
Completed NCT04137263 - Study Evaluating the Efficacy of DOSE Formulations in Treating Melasma and Cutaneous Signs of Aging N/A
Recruiting NCT03686787 - Oral Tranexamic Acid and Laser for Treatment of Melasma Phase 4
Completed NCT05969587 - Cysteamine Compared to Hydroquinone in Melasma Phase 3
Completed NCT00500162 - Comparison of Two Tri-Luma® Maintenance Regimens in the Treatment of Melasma Phase 4
Completed NCT00472966 - Efficacy and Safety of Therapy With Tri-Luma® Cream in Sequence With Glycolic Acid Peels for Melasma Phase 4
Completed NCT05887219 - Comparison of Azelaic Acid 20 % Cream Versus Hydroquinone 4% Cream as an Adjuvant to Oral Tranexamic Acid in Melasma Phase 1
Completed NCT05884151 - Comparison of Intralesional Tranexamic Acid and Platelets Rich Plasma in the Treatment of Melasma Phase 1
Recruiting NCT03308370 - Platelet Rich Plasma in Treatment of Melasma Phase 3