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

Provectus Biopharmaceuticals

Status and phase

Completed

Phase 2

Conditions

Atopic Dermatitis

Treatments

Drug: PH-10

Study type

Interventional

Funder types

Industry

Identifiers

NCT00690807

PH-10-AD-21

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.