Trial | NCT00991198  Report issue

Title

The Role of Topically Dissolved Oxygen (TDO) to Ameliorate Signs of Photodamage
The Role of Topically Dissolved Oxygen (TDO) to Ameliorate Signs of Photodamage in Individuals With Multiple Skin Conditions A Double-Blind, Placebo Controlled Comparative Trial

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    oxygen ...

  • Study Participants

    49
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.
Study Started
Sep 30
2009
Primary Completion
Jan 31
2010
Study Completion
Jan 31
2010
Last Update
Jun 08
2011
Estimate

Drug Topical oxygen

0.5% concentration of Topical oxygen

Drug Topical oxygen

0.25% concentration topical oxygen

Drug placebo

no O2

A Experimental

Aria Regimens 0.5% conc

B Experimental

Aria Regimen (5 products) 0.25% conc

C Placebo Comparator

Aria Regimen Control without O2

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).
No Results Posted