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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00991198
Other study ID # IFLOTDO002
Secondary ID
Status Completed
Phase Phase 2
First received October 6, 2009
Last updated June 6, 2011
Start date September 2009
Est. completion date January 2010

Study information

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

Clinical Trial 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.


Recruitment information / eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment


Intervention

Drug:
Topical oxygen
0.5% concentration of Topical oxygen
Topical oxygen
0.25% concentration topical oxygen
placebo
no O2

Locations

Country Name City State
United States Dermatology Consultants Inc High Point North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Aria Aesthetics Inc.

Country where clinical trial is conducted

United States, 

Outcome

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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