The Role of Topically Dissolved Oxygen (TDO) to Ameliorate Signs of Photodamage
NCT ID: NCT00991198
Last Updated: 2011-06-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
49 participants
INTERVENTIONAL
2009-09-30
2010-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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A
Aria Regimens 0.5% conc
Topical oxygen
0.5% concentration of Topical oxygen
B
Aria Regimen (5 products) 0.25% conc
Topical oxygen
0.25% concentration topical oxygen
C
Aria Regimen Control without O2
placebo
no O2
Interventions
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Topical oxygen
0.5% concentration of Topical oxygen
Topical oxygen
0.25% concentration topical oxygen
placebo
no O2
Eligibility Criteria
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Inclusion Criteria
* Subjects must be Fitzpatrick Types I, II, III, IV, V
* Subjects must be willing to forgo the use of facial cosmetics (e.g. facial moisturizers,creams, foundations, blush, etc.) during the course of the study.
* Subjects may ONLY use facial regimen of products provided by sponsor(lipstick, lip gloss, and eye mascara permitted).
Exclusion Criteria
* Routine high dosage use of anti-inflammatory medications (aspirin, ibuprofen, corticosteroids), immunosuppressive drugs or antihistamine medications (steroid nose drops and/or eye drops are permitted) (one-8lmg or 325mg aspirin okay) (birth control is okay but needs to be reported).
* Use of topical OTC/Rx drugs or other cosmetics at the test sites.
* Immunological disorders such as HIV positive and systemic lupus erythematosus (interview only)
* Participation in any clinical study within the last four weeks.
* Pregnant or lactating women (interview only).
* Damaged skin in or around test sites (including sunburn, uneven skin tones, tattoos, scars or other disfiguration of the test site).
25 Years
60 Years
FEMALE
No
Sponsors
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Aria Aesthetics Inc.
INDUSTRY
Responsible Party
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Aria Aesthetics, Inc.
Principal Investigators
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Zoe D Draelos, MD
Role: PRINCIPAL_INVESTIGATOR
Dermatology Consultants Inc.
Locations
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Dermatology Consultants Inc
High Point, North Carolina, United States
Countries
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Other Identifiers
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IFLOTDO002
Identifier Type: -
Identifier Source: org_study_id
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