Atopic Dermatitis Clinical Trial
Official 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
Verified date | June 2011 |
Source | Aria Aesthetics Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 49 |
Est. completion date | January 2010 |
Est. primary completion date | January 2010 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 25 Years to 60 Years |
Eligibility |
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). |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Dermatology Consultants Inc | High Point | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Aria Aesthetics Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | skin grading evaluation of photodamage | 8 weeks | No | |
Secondary | stratum corneum hydration (skin capacitance) | 8 weeks | No | |
Secondary | bioinstrumental assessment of skin "melanin" lightening, and lesional erythematous sites | 8 weeks | No | |
Secondary | bioinstrumental assessment of skin texture, scaliness (desquamation) | 8 weeks | No | |
Secondary | punch biopsy histopathologic examination (H&E, and immunohistochemistry for Aquaporin 3, and Filaggrin) | 8 weeks | No | |
Secondary | RT-PCR collagenase , and hypoxia-inducible factor-1 alpha | 8 weeks | No | |
Secondary | product performance | 8 weeks | Yes |
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