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

Phase 2

Completed

• Conditions: Rosacea; Acne Vulgaris; Atopic Dermatitis; Seborrheic Dermatitis
• Interventions: Drug: Topical oxygen; Drug: placebo

• Registration Number: NCT00991198
• Lead Sponsor: Aria Aesthetics Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-10-06
• Study First Submitted QC: 2009-10-06
• Study First Posted: 2009-10-07
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-06
• Last Update Posted: 2011-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 49

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Topical oxygen	Aria Regimens 0.5% conc
B	Topical oxygen	Aria Regimen (5 products) 0.25% conc
C	placebo	Aria Regimen Control without O2

Primary Outcome Measures

Name	Time	Method
skin grading evaluation of photodamage	8 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Dermatology Consultants Inc; 🇺🇸 High Point, North Carolina, United States