PDA making its mark

Key Points

"Our group has been successful in crafting a number of publications based on extensive literature review and PDA member expert opinion. These papers ... are intended to improve knowledge and awareness about pigmentary disorders, as well as facilitate the proper design of clinical trials. Now, we are moving forward into a new research phase and have begun to undertake studies that we believe will further advance understanding of pigmentary disorders," says Amit G. Pandya, M.D., professor of dermatology, University of Texas Southwestern Medical School, Dallas.

PDA with a purpose

"Findings from an increasing number of studies underline the importance of melasma by demonstrating it is a very common disorder and one with a significant impact on quality of life," Dr. Pandya says.

In a supplement to the British Journal of Dermatology in December 2006, the PDA published several papers relating to melasma, including an article about ethnic considerations in the treatment of Hispanic and Latin American patients with hyperpigmentation, a validation study of a Brazilian Portuguese version of the Melas-QoL and its use to measure quality of life improvement in melasma patients receiving triple combination therapy (TriLuma Cream, Galderma), and a paper presenting guidelines for melasma clinical trials.

"We considered the latter to be an especially important accomplishment because we felt the lack of any standards for conducting this type of research contributes to design flaws that limit study validity," Dr. Pandya tells Dermatology Times.

Based on discussions initiated at an annual meeting, the PDA members also designed and undertook a multinational survey to gain better insight about the epidemiology of melasma. The survey was in both English and Spanish versions, and was orally administered to individuals who could not read either of those languages.

The questions were designed to gather information about age of melasma onset, associations with oral contraceptive use, menopause and sun exposure, as well as disease chronicity. The survey was administered by PDA members to their own patients, and, at press time, 300 completed questionnaires had been collected and were being analyzed.

"This initial effort may be considered a pilot study, and based on the findings, we will determine what issues need to be explored in larger patient populations in order to get more definitive answers about these issues," Dr. Pandya says.

Further research

Dr. Pandya explains that the group is hoping to use the data to guide the design of a future study that will explore optimum maintenance therapy to prevent melasma recurrence.

The PDA is also preparing to embark on a project to develop a validated and reproducible tool for rating melasma severity. When the six members of the PDA steering committee gather in Dallas, they will be evaluating the Melasma Area and Severity Index (MASI) in a series of melasma patients.

"The MASI score and other measures are being used in clinical studies of melasma, but reliability has never been demonstrated for any of those tools. Therefore, interpretation of reported results is difficult," Dr. Pandya says.

The group is also beginning work to develop computer-based techniques for measuring area of involvement of melasma. As new instrumentation has become available to objectively quantify pigmentation in the skin, the PDA is also planning to assess that technology to determine its role in the evaluation of melasma.

"These instruments hold promise to provide an accurate determination of pigmentation severity, as well as location in the skin, and we will be beginning to investigate their potential role by seeing how well their readings correlate with the results of currently available assessment techniques," Dr. Pandya says.

Outside of melasma, the PDA has on its upcoming agenda a project to develop a validated and reliable tool for grading postinflammatory hyperpigmentation (PIH) severity. To lay the groundwork, Dr. Pandya is conducting focus sessions to acquire patient feedback on what aspects of their PIH are most bothersome.