A Phase 2 Study of Cellular and Immunologic Changes in the Skin of Subjects Receiving PH-10
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Psoriasis |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | January 2015 |
| End Date: | January 2016 |
A Phase 2 Study of Cellular and Immunologic Changes in the Skin of Subjects Receiving PH-10 Aqueous Hydrogel to Plaque Psoriasis
This is a multicenter study of subjects with mild to moderate psoriasis. Subjects will apply
PH-10 vehicle daily for 28 consecutive days followed by active PH-10 daily for 28
consecutive days to their plaque psoriasis areas on the trunk or extremities (excluding
palms, soles, scalp, facial and intertriginous sites). Biopsies of one target plaque will be
collected at baseline (at least 7 days prior to first study treatment on Day 1) and at Days
29 and 64, with a 7-day interval between biopsy at Day 29 and commencement of application of
application of active PH-10 on Day 36. Study data from each subject will serve as an
internal control (i.e., assessment at baseline and at the end of application of PH-10
vehicle) for assessment of clinical and cellular response to active investigational agent.
PH-10 vehicle daily for 28 consecutive days followed by active PH-10 daily for 28
consecutive days to their plaque psoriasis areas on the trunk or extremities (excluding
palms, soles, scalp, facial and intertriginous sites). Biopsies of one target plaque will be
collected at baseline (at least 7 days prior to first study treatment on Day 1) and at Days
29 and 64, with a 7-day interval between biopsy at Day 29 and commencement of application of
application of active PH-10 on Day 36. Study data from each subject will serve as an
internal control (i.e., assessment at baseline and at the end of application of PH-10
vehicle) for assessment of clinical and cellular response to active investigational agent.
Inclusion Criteria:
- Men or women, age 18 or older.
- Presence of mild to moderate plaque psoriasis on the trunk or extremities (excluding
palms, soles, scalp, and facial or intertriginous areas).
- At least one target plaque having a minimum diameter of 5 cm (2 inches) with uniform
mild to moderate plaque psoriasis.
- Fitzpatrick skin type I-VI.
- Written informed consent by the subject or legal guardian.
Exclusion Criteria:
- Female subjects of childbearing potential who are pregnant, attempting to conceive,
not using effective contraception, or who are nursing an infant.
- Subjects who have received PH-10.
- Subjects who have received PUVA or systemic antipsoriatic therapy
(immunosuppressants, cytostatics, corticosteroids) within 28 days of study initiation
(14 days for methotrexate).
- Subjects who have received UVB light therapy within 14 days of study initiation.
- Subjects who have received topical antipsoriatic therapy (including corticosteroids,
tar, anthralin or Vitamin D analogs) to the study plaque areas within 14 days of
study initiation.
- Subjects who have received any approved or investigational biologic drug therapy for
psoriasis within 90 days or 5 half-lives of study initiation.
- Subjects who have participated in a clinical research study within 28 days of study
initiation.
- Subjects with a history of porphyria, systemic lupus erythematosus or xeroderma
pigmentosum.
- Subjects with clinical conditions that, in the opinion of the Investigator, may pose
a health risk to the subject because of involvement in the study or detrimentally
affect regular follow-up of the subject.
We found this trial at
3
sites
333 South Columbia Street
Chapel Hill, North Carolina 27599
Chapel Hill, North Carolina 27599
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