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

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00690807
• Other study ID #: PH-10-AD-21
• Status: Completed
• Phase: Phase 2
• First received: June 3, 2008
• Last updated: September 24, 2009
• Start date: June 2008
• Est. completion date: September 2009

Study information

• Verified date: September 2009
• Source: Provectus Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

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

Locations

Country	Name	City	State
United States	International Dermatology Research	Miami	Florida
United States	Mount Sinai School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Provectus Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		28 days	No
Primary	Adverse experience, including pain and dermatologic/skin toxicity (incidence, severity, frequency, duration and causality).		8 weeks	Yes
Secondary	Investigator's Global Assessment (IGA) score changes at each visit from Day 1 pre-treatment.		8 weeks	No
Secondary	Eczema Area Severity Index (EASI) score changes of individual atopic dermatitis signs at each visit from Day 1 pre-treatment.		8 weeks	No
Secondary	Pruritus Self-Assessment score changes of atopic dermatitis related itching/scratching at each visit from Day 1 pre-treatment.		8 weeks	No
Secondary	Adverse change in clinical laboratory tests (CBC and CMP).		8 weeks	Yes
Secondary	Adverse change in vital signs (BP, pulse, temperature).		8 weeks	Yes