The Role of Topically Dissolved Oxygen (TDO) to Ameliorate Signs of Photodamage

• Status: Completed
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: Female

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. Evaluation of the overall skin tolerability of topical dissolved oxygen (safety) utilizing the regimen of products.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aria Aesthetics Inc.

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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).