Status:
COMPLETED
The Role of Topically Dissolved Oxygen (TDO) to Ameliorate Signs of Photodamage
Lead Sponsor:
Aria Aesthetics Inc.
Conditions:
Rosacea
Acne Vulgaris
Eligibility:
FEMALE
25-60 years
Phase:
PHASE2
Brief Summary
This study is an evaluation of the role of topical dissolved oxygen to lessen visible signs of photodamage using a select regimen of topical dissolved oxygen containing cosmeceutical products. Evaluat...
Eligibility Criteria
Inclusion
- Subjects must be female, 25-60 years old in good general health;
- 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
- Known sensitivity to any of the test material ingredients.
- 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).
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT00991198
Start Date
September 1 2009
End Date
January 1 2010
Last Update
June 8 2011
Active Locations (1)
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1
Dermatology Consultants Inc
High Point, North Carolina, United States, 27262