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CompletedNCT00941278Updated Jul 7, 2010

An Efficacy and Safety Study of PH-10 Aqueous Hydrogel for the Treatment of Plaque Psoriasis

A Phase 2 interventional study of PH-10 (0.001% Rose Bengal) in Psoriasis, sponsored by Provectus Pharmaceuticals. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-07-07.

Sponsored by Provectus Pharmaceuticals · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

PH-10 is an aqueous hydrogel formulation of rose bengal disodium (RB) for topical administration to the skin, and is being studied for the treatment of cutaneous skin disorders, specifically psoriasis and atopic dermatitis. This phase 2 efficacy and safety study will assess topical PH-10 applied once daily to areas of mild to moderate plaque psoriasis.

02

Conditions studied

  • Psoriasis

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03

In context

Psoriasis

1,928 studies on the registry are indexed under Psoriasis; 234 are open to participants now.

This study's planned enrollment of 30 is below the median of 70 across 1,472 interventional studies indexed under Psoriasis.

Browse Psoriasis studies →

Lead sponsor

Provectus Pharmaceuticals is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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).
  • Fitzpatrick skin type I-VI.
  • Written informed consent by the subject or legal guardian.

Exclusion criteria

Exclusion Criteria:

  • Women of childbearing potential who are pregnant, attempting to conceive, not using effective contraception, or who are nursing an infant.
  • Subjects who have received PUVA or systemic antipsoriatic therapy (immunosuppressants, cytostatics, corticosteroids) within 28 days of study initiation (two weeks 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 agents posing a clinically significant risk of photosensitivity reaction within 5 half-lives 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 by being involved in the study or detrimentally affect regular follow-up of the subject.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    PH-10 Treatment

    Drug: PH-10 (0.001% Rose Bengal)

Interventions

06

What researchers measure

Primary outcomes

  1. The primary efficacy endpoint is "Treatment Success," a static endpoint assessed at Day 29 after initial PH-10 treatment and defined as 0 or 1 on all Psoriasis Severity Index (PSI) components and 0 or 1 on the Plaque Response scale.

    Time frame: 28 days

  2. The primary safety endpoint is incidence of adverse experiences, including pain and dermatologic/skin toxicity (incidence, severity, frequency, duration and causality).

    Time frame: 8 weeks

Secondary outcomes

  1. Psoriasis Severity Index (PSI) score changes at each visit from Day 1 pre-treatment.

    Time frame: 8 weeks

  2. Plaque Response score changes at each visit from Day 1 pre-treatment.

    Time frame: 8 weeks

  3. Pruritus Self-Assessment score changes at each visit from Day 1 pre-treatment.

    Time frame: 8 weeks

07

Study locations

2 sites
  • International Dermatology Research
    Miami, Florida 33144, United States
  • Mount Sinai School of Medicine
    New York, New York 10029, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 7, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00941278
Lead sponsor
Provectus Pharmaceuticals
First posted
Jul 17, 2009
Start date
Jul 2009
Primary completion
Dec 2009
Completion
Apr 2010
Last update
Jul 7, 2010

Study contacts

Eric Wachter, PhD
study director · Provectus Pharmaceuticals

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2010. You cannot join it, but the record below documents what was studied.

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