Clinical Trial Review

January 2012 | Volume 11 | Issue 1 | Features | 134 | Copyright © January 2012

Clinical Trial Review is a JDD department designed to provide physicians with information on drugs and devices undergoing clinical testing. It is our goal to inform the reader of the status of select drug and device studies relevant to the practice of dermatology before this information is available through standard channels. To participate in or learn more about these and additional trials, visit


Study of Laser Treatment of Melasma

Sponsored by ConBio, this study aims to evaluate the RevLite laser with Smart Infinite (SI) Handpiece in the treatment of refractory mixed type melasma. The primary outcome measures use the Melasma Area Severity Assessment (MASI) in the timeframe of three months to assess the severity of the melasma in each of the four regions (forehead, right malar region, left malar region, and chin), based on three variables: percentage of the total area involved (A), darkness (D), and homogeneity (H).
Inclusion criteria: Fitzpatrick Skin Type III-VI, mixed (epidermal and dermal) melasma diagnosed by Wood's Lamp exam, age 18 or older, melasma persisting for greater than 6 months that has failed to respond to conventional treatment with hydroquinone or other topical lightening agents, written and verbal informed consent, and willing and able to comply with study instructions and return to the clinic for required visits.
Exclusion criteria: Pregnancy, breastfeeding, taking birth control pills or plans to become pregnant during the study; history of cutaneous photosensitization, porphyria, and hypersensitivity to porphyrins or photodermatosis; any skin pathology or condition that could interfere with the evaluation or requires the use of interfering topical or systemic therapy; uncorrected coagulation defect or is currently using anti-coagulation medication (including but not limited to heavy aspirin therapy); any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study; currently enrolled in an investigational drug or device trial, or has received an investigational drug or has been treated with an investigational device within 30 days prior to entering this study; inability to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function; unreliability for the study (this includes subjects who engage in excessive alcohol intake or drug abuse, or subjects who are unable to return for scheduled follow-up visits); use of photosensitizing drugs within a timeframe where photosensitization from these drugs may still be present; need to be exposed to artificial tanning devices or excessive sunlight during the trial; Diabetes Type I or II; sensitivity to hydroquinone or Retin-A; evidence of a compromised immune system or hepatitis; use of bleaching creams or retinoids within the last 30 days.
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A Clinical Study Evaluating the Efficacy, Safety, and Patient Satisfaction of Injectable Hyaluronic Acid With 0.3% Lidocaine Hydrochloride, Prevelle Silk, for Superficial, Vertical Perioral Lines and Superficial, Horizontal, Lateral Canthal Lines
Sponsored by Goldman, Butterwick, Fitzpatrick, and Groff, in collaboration with Mentor Worldwide, LLC, this prospective study aims to determine if there is a difference in the reduction of lines in the treated areas as compared to baseline.
Inclusion criteria: Females and males in good general health between 35 to 65 years of age; must be willing to give and sign a HIPAA form, informed consent form and a photographic release form; patient is planning to undergo Prevelle Silk treatment; exhibit moderate to severe superficial, vertical perioral, and horizontal canthus lines; must be willing to comply with study regimen and complete the entire course of the study; and, if female, must have had a regular menstrual cycle prior to study entry and is willing to use an acceptable form of birth control during the entire course of the study.
Exclusion criteria: A patient with any uncontrolled systemic disease; has a significant history or current evidence of a medical, psychological or other disorder that, in the investigator's opinion, would preclude enrollment into the study; is actively smoking or plans to smoke at any time of the duration of this study; has an active skin condition/disease that might interfere with the diagnosis or evaluation of study parameters; any other cosmetic procedure to their facial area during the study