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Completed

NCT Number: NCT00991198

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Topical oxygen

Drug

0.5% concentration of Topical oxygen

Placebo

Drug

no O2

Primary outcomes

  1. skin grading evaluation of photodamage

    Time frame: 8 weeks

Secondary outcomes

  1. stratum corneum hydration (skin capacitance)

    Time frame: 8 weeks

  2. bioinstrumental assessment of skin "melanin" lightening, and lesional erythematous sites

    Time frame: 8 weeks

  3. bioinstrumental assessment of skin texture, scaliness (desquamation)

    Time frame: 8 weeks

  4. punch biopsy histopathologic examination (H&E, and immunohistochemistry for Aquaporin 3, and Filaggrin)

    Time frame: 8 weeks

  5. RT-PCR collagenase , and hypoxia-inducible factor-1 alpha

    Time frame: 8 weeks

  6. product performance

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Aria Aesthetics Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Oct 7, 2009
Registry last updated
Jun 8, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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