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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Aria Regimens 0.5% conc |
|
| B | Experimental | Aria Regimen (5 products) 0.25% conc |
|
| C | Placebo Comparator | Aria Regimen Control without O2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topical oxygen | Drug | 0.5% concentration of Topical oxygen |
| |
| Topical oxygen |
| Measure | Description | Time Frame |
|---|---|---|
| skin grading evaluation of photodamage | 8 weeks |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zoe D Draelos, MD | Dermatology Consultants Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermatology Consultants Inc | High Point | North Carolina | 27262 | United States |
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| ID | Term |
|---|---|
| D012393 | Rosacea |
| D000152 | Acne Vulgaris |
| D003876 | Dermatitis, Atopic |
| D012628 | Dermatitis, Seborrheic |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017486 | Acneiform Eruptions |
| D012625 | Sebaceous Gland Diseases |
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| ID | Term |
|---|---|
| D010100 | Oxygen |
| ID | Term |
|---|---|
| D018011 | Chalcogens |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
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| Drug |
0.25% concentration topical oxygen |
|
| placebo | Drug | no O2 |
|
| 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 |
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D017444 | Skin Diseases, Papulosquamous |