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Completed

NCT Number: NCT00690807

A Phase 2 Study of PH-10 for the Treatment of Atopic Dermatitis

PH-10 is a formulation of rose bengal disodium (RB) for topical administration to the skin. PH-10 is capable of undergoing photochemical reactions when activated by ambient light. This phase 2 study will assess whether topical PH-10 applied once daily to mild, moderate or severe areas of atopic dermatitis (including atopic eczema) may ameliorate inflammation of the skin when activated by ambient light.

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Eczema Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

International Dermatology Research, Miami, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men or women, age 18 or older.
  • Mild, moderate or severe atopic dermatitis.
  • Presence of atopic dermatitis areas outside the head and face with a baseline Investigator Global Assessment (IGA) of 2 (mild disease), 3 (moderate) or 4 (severe disease) at screening.
  • Written informed consent by the subject or legal guardian.

Exclusion criteria

  • Women who are pregnant, attempting to conceive, or nursing an infant.
  • Subjects who have received phototherapy (UVB, PUVA) or systemic therapy (immunosuppressants, cytostatics, corticosteroids) within 4 weeks.
  • Subjects who have received systemic antibiotics within 2 weeks.
  • Subjects who have received topical therapy (tar, corticosteroids) within 7 days.
  • Subjects who have received investigational drugs in a clinical research study within 4 weeks.
  • Subjects who have received agents posing a clinically significant risk of photosensitivity reaction within 5 half-lives of initiation of study treatment.
  • Subjects with a history of porphyria, systemic lupus erythematosus or xeroderma pigmentosum.
  • Subjects with clinical conditions that may pose a health risk to the subject by being involved in the study or detrimentally affect regular follow-up of the subject.

Treatment and study plan

PH-10

Drug

PH-10 will be applied daily for 28 days to skin areas affected by atopic dermatitis.

Primary outcomes

  1. The primary efficacy endpoint is "Treatment Success," a static endpoint defined as a score of 0 to 1 at Day 28 (at the end of the study treatment period) by the Investigator's Global Assessment (IGA) scoring system for atopic dermatitis status.

    Time frame: 28 days

  2. Adverse experience, including pain and dermatologic/skin toxicity (incidence, severity, frequency, duration and causality).

    Time frame: 8 weeks

Secondary outcomes

  1. Investigator's Global Assessment (IGA) score changes at each visit from Day 1 pre-treatment.

    Time frame: 8 weeks

  2. Eczema Area Severity Index (EASI) score changes of individual atopic dermatitis signs at each visit from Day 1 pre-treatment.

    Time frame: 8 weeks

  3. Pruritus Self-Assessment score changes of atopic dermatitis related itching/scratching at each visit from Day 1 pre-treatment.

    Time frame: 8 weeks

  4. Adverse change in clinical laboratory tests (CBC and CMP).

    Time frame: 8 weeks

  5. Adverse change in vital signs (BP, pulse, temperature).

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Provectus Pharmaceuticals

Industry

Registry information

Official study title

A Phase 2 Efficacy and Safety Study of PH-10 Aqueous Hydrogel for the Treatment of Atopic Dermatitis

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jun 5, 2008
Registry last updated
Sep 28, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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