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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Rosacea, Acne Vulgaris, Atopic Dermatitis, Seborrheic Dermatitis

Intervention / Treatment
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* Drug: Topical oxygen
* Drug: Topical oxygen
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Aria Regimens 0.5% conc | Drug: Topical oxygen<br>* 0.5% concentration of Topical oxygen<br>|
| Experimental: B<br>Aria Regimen (5 products) 0.25% conc | Drug: Topical oxygen<br>* 0.25% concentration topical oxygen<br>|
| Placebo Comparator: C<br>Aria Regimen Control without O2 | Drug: placebo<br>* no O2<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| skin grading evaluation of photodamage |  | 8 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Topically dissolved oxygen, inflammatory cutaneous disease, rosacea, acne vulgaris, atopic dermatitis, seborrheic dermatitis, photodamage