Phosphate Cream in Subjects With Vitiligo

What we are studying

This is a randomized, double-blind, dose ranging, placebo controlled Study in subjects with vitiligo. Double blind means that neither you nor the Study Doctor will know if you will receive Study Drug or a placebo called “the vehicle cream”, this is a cream without active drug. A method called “randomization” will be used to decide if you will receive Study Drug or vehicle cream. Randomization means that you will be assigned to a treatment group by chance which is similar to a coin toss. You may be assigned a treatment group using Study Drug or you may be assigned a treatment group using vehicle cream. “Dose-ranging” means that different doses of the Study Drug will also be assigned. The Study will have 3 treatment periods: 2 randomized, double blinded, dose ranging and one open label, single dose treatment. Part 1 will be for the first 24 weeks, and you will be randomly assigned to one of the five treatments groups. Four of the five treatment groups will receive the Study Drug in various dosages: 1.5% twice daily, 1.5% once daily, 0.5% once daily, or 0.15% once daily, and the fifth group will receive vehicle cream that does not have any medicine. Each group will have about 30 subjects. You will have an equal chance of being in one of the five treatment groups. Your chances to receive the Study Drug in Part 1 are 4 out of 5. You will apply the Cream twice daily, however your Cream may contain Study Drug in only one of the applications per day. Part 2 will be an additional 28 week double-blind treatment period with a new treatment assignment for the group that did not receive the Study drug in Part 1. This group will be randomly assigned to 3 higher doses: 1.5% twice daily, 1.5% once daily, and 0.5% once daily. The group that received 0.15% once daily could be randomized to the one of 3 higher dosage groups, based on the assessment of the vitiligo improvement. If at least a 25% improvement is achieved, you will remain in your original group. If not, you will be re-assigned to receive a higher dose of Study Drug. If you were randomized to the 3 higher dose treatment group in Part 1 you will remain on the same dose in Part 2. You will continue to apply the Cream twice daily. Part 3 will be a 52 week open-label period. “Open-label” means you will know what dosage of Study Drug you are receiving. After the Study assessments at week 52 and based on your Study Doctor’s evaluation, you may be offered to receive an additional 52 weeks of the Study Drug at the highest dosage. If you have full return of skin color on your face, you will have the option to continue the Study Drug twice a day, decrease to once a day, or stop treatment and observe the response. You may discuss these options with your Study Doctor. Additionally, if your pigment has not returned satisfactorily, your Study Doctor in consultation with the Sponsor may offer you treatment with a low-dose UVB phototherapy in addition to the Study Drug. It is possible that phototherapy may increase your response to the Study Drug.

Who is Eligible

  • Genders:
    • Men
    • Women
  • Races:
    • White
    • African American
  • Not Hispanic or Latino
  • Ages 12 - 75

Eligibility Criteria

  • Subjects with a clinical diagnosis of vitiligo
  • Subjects with vitiligo with depigmented areas including; 1) at least 0.5% of the total BSA on the face (0.5% BSA is approximately equal to the area of the subject's palm [without digits]) AND 2) at least 3% of the total BSA on nonfacial areas (3% BSA is approximately equal to the area of 3 of the subject's handprints [palm plus 5 digits])
  • Subjects who agree to discontinue all agents used to treat vitiligo from screening through the final follow-up visit. Over-the-counter preparations deemed acceptable by the investigator and nonocclusive camouflage makeups are permitted

What is involved

  • Screening Visit - Physical Exam including height and body weight; vital signs (blood pressure; heart rate; breathing rate and body temperature will be measured; Urine and Blood samples will be collected for laboratory tests; Electrocardiogram (ECG); Digital Photographs will be taken of your face and body areas affected with vitiligo
  • Visit 1; Physical exam; Vital Signs; Urine Pregnancy Test; Blood sample; subject questionnaires; Photographs
  • Week 4 - Brief Physical Exam; Vital signs; urine pregnancy test (if applicable); Blood sample; Photographs
  • Week 8 - Brief Physical Exam; Vital signs; urine pregnancy test (if applicable); Photographs
  • Week 12 - Brief Physical Exam; Vital signs; urine pregnancy test (if applicable); Blood sample; Photographs
  • Week 18 - Brief Physical Exam; Vital signs; urine pregnancy test (if applicable); Photographs
  • Week 24 - Physical Exam; Vital signs; urine pregnancy test (if applicable); Blood sample; Photographs
  • Week 28 - Brief Physical Exam; vital signs; urine pregnancy test (if applicable)
  • Week 34 - Brief Physical Exam; vital signs; urine pregnancy test (if applicable)
  • Week 40 - Brief Physical Exam; Vital signs; urine pregnancy test (if applicable); Blood sample; Photographs
  • Week 46 - Brief Physical Exam; vital signs; urine pregnancy test (if applicable)
  • Week 52 - Physical Exam; Vital signs; urine pregnancy test (if applicable); Blood sample; Photographs; Skin sample
  • Week 56 - Brief Physical Exam; vital signs; urine pregnancy test (if applicable)
  • Week 68 - Brief Physical Exam; vital signs; urine pregnancy test (if applicable); photographs
  • Week 80 - Brief Physical Exam; vital signs; urine pregnancy test (if applicable); blood sample; skin sample; photographs
  • Week 92 -Brief Physical Exam; vital signs; urine pregnancy test (if applicable); photographs
  • Week 104 -Physical Exam; vital signs; urine pregnancy test (if applicable); ECG; Blood sample; skin sample; photographs
  • Month 1 Follow-up - Brief physical exam; vital signs; blood sample; urine pregnancy test (if applicable)
  • Month 3 Follow-up - Brief physical exam; vital signs; blood sample; urine pregnancy test (if applicable); skin sample; photographs

Compensation

$50 per completed visit for a total of $1,100 if all visits are completed.

Contact Information

Study Coordinator
Dermatology Clinical Studies
Email
dermadvertising@wakehealth.edu
Phone
336-716-3775

Disclaimer: The information on this website is for general informational purposes only and SHOULD NOT be relied upon as a substitute for sound professional medical advice, evaluation or care from your physician or other qualified health care provider.