Full Text View
Tabular View
No Study Results Posted
Related Studies
A Phase 2 Study of PH-10 for the Treatment of Atopic Dermatitis
This study has been completed.
Study NCT00690807   Information provided by Provectus Pharmaceuticals
First Received: June 3, 2008   Last Updated: September 24, 2009   History of Changes

June 3, 2008
September 24, 2009
June 2008
August 2009   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: No ]
  • Adverse experience, including pain and dermatologic/skin toxicity (incidence, severity, frequency, duration and causality). [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00690807 on ClinicalTrials.gov Archive Site
  • Investigator's Global Assessment (IGA) score changes at each visit from Day 1 pre-treatment. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Eczema Area Severity Index (EASI) score changes of individual atopic dermatitis signs at each visit from Day 1 pre-treatment. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Pruritus Self-Assessment score changes of atopic dermatitis related itching/scratching at each visit from Day 1 pre-treatment. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Adverse change in clinical laboratory tests (CBC and CMP). [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • Adverse change in vital signs (BP, pulse, temperature). [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Same as current
 
A Phase 2 Study of PH-10 for the Treatment of Atopic Dermatitis
A Phase 2 Efficacy and Safety Study of PH-10 Aqueous Hydrogel 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.

 
Phase II
Interventional
Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Atopic Dermatitis
Drug: PH-10
Experimental: PH-10 treatment
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
30
September 2009
August 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00690807
Eric Wachter, Vice President, Provectus Pharmaceuticals, Inc.
PH-10-AD-21
Provectus Pharmaceuticals
 
Principal Investigator: Alicia Barba, MD International Dermatology Research
Provectus Pharmaceuticals
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP