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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00991198

Enrollment

Registered

2009-10-07

Start date

2009-09-30

Completion date

2010-01-31

Last updated

2011-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acne Vulgaris, Atopic Dermatitis, Rosacea, Seborrheic Dermatitis

Keywords

Topically dissolved oxygen, inflammatory cutaneous disease, rosacea, acne vulgaris, atopic dermatitis, seborrheic dermatitis, photodamage

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

Interventions

DRUGTopical oxygen

0.5% concentration of Topical oxygen

DRUGplacebo

no O2

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

25 Years to 60 Years

Healthy volunteers

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).

Design outcomes

Primary

Measure	Time frame
skin grading evaluation of photodamage	8 weeks

Secondary

Measure	Time frame
bioinstrumental assessment of skin melanin lightening, and lesional erythematous sites	8 weeks
bioinstrumental assessment of skin texture, scaliness (desquamation)	8 weeks
stratum corneum hydration (skin capacitance)	8 weeks
RT-PCR collagenase , and hypoxia-inducible factor-1 alpha	8 weeks
product performance	8 weeks
punch biopsy histopathologic examination (H&E, and immunohistochemistry for Aquaporin 3, and Filaggrin)	8 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026