On March 8, 2021, FDA is conducting a virtual (online only) public meeting on Patient-Focused Drug Development for Vitiligo. The public meeting is intended to allow FDA to obtain patient perspectives on the impact of vitiligo, including on daily life, patient views on treatment approaches, and decision factors taken into account when selecting a treatment.

The questions that will be asked of patients and patient stakeholders at the meeting are listed below, organized by topic. For each topic, a brief initial patient panel discussion will begin the dialogue. This will be followed by a facilitated discussion inviting comments from other patient and patient stakeholder participants in the audience.  

If you are a patient or patient representative interested in providing comments as part of a panel discussion, please indicate so during the registration process. Potential panelists must send a brief summary of responses to the discussion questions below by February 15th to PatientFocused@fda.hhs.gov. Panelists will be confirmed prior to the meeting.

For more information, please visit the FDA meeting website: https://www.fda.gov/drugs/news-events-human-drugs/public-meeting-patient-focused-drug-development-vitiligo-03082021-03082021

DISCUSSION QUESTIONS

Topic 1: Health effects and daily impacts that matter most to patients

1. Which aspects of vitiligo have the most significant impact on your life? (Examples may include depigmentation, itching, sensitivity to sunlight, etc.)

2. Are there specific activities that are important to you but that you cannot do at all or as fully as you would like because of your vitiligo? (Examples of activities may include participating in social events, playing sports, being outside in the sunlight, etc.)

a. How does your vitiligo and its impacts affect your daily life on the best days? On the worst days?

3. How has your vitiligo changed over time?

a. How has your vitiligo changed from childhood to adulthood (such as vitiligo severity, disease acceptance)?

b. Would you define your vitiligo today as being well-managed?

4. What worries you most about your vitiligo?

a. Is there a particular body area affected by vitiligo (such as face, hands, limbs) that is of most concern to you?

Topic 2: Patients’ perspectives on current approaches to treatment

1. What are you currently doing to help treat your vitiligo? (Examples may include prescription medicines, over-the-counter products, and other therapies including non-drug therapies such as diet modification.)

a. How has your treatment regimen changed over time, and why?

2. How well does your current treatment regimen treat the most significant aspects of your vitiligo? For example, how well do your treatments improve your ability to do specific activities?

3. What are the most significant downsides to your current treatments, and how do they affect your daily life? (Examples of downsides may include bothersome side effects, depigmentation of affected area is more noticeable, hospital treatments, etc.)

4. Assuming there is no complete cure for your vitiligo, what specific things would you look for in an ideal treatment for your vitiligo?

a. Is there a particular body area affected by vitiligo (such as face, hands, limbs) that you would prioritize for treatment?

5. What factors do you consider when making decisions about selecting a course of treatment?