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

Sponsor

Aria Aesthetics Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00991198

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

12.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rosacea Acne Vulgaris Atopic Dermatitis Seborrheic Dermatitis	Drug: Topical oxygen Drug: Topical oxygen Drug: placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

49 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

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

Study Start Date :

Sep 1, 2009

Actual Primary Completion Date :

Jan 1, 2010

Actual Study Completion Date :

Jan 1, 2010

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: A

Aria Regimens 0.5% conc

Drug: Topical oxygen

0.5% concentration of Topical oxygen

Experimental: B

Aria Regimen (5 products) 0.25% conc

Drug: Topical oxygen

0.25% concentration topical oxygen

Placebo Comparator: C

Aria Regimen Control without O2

Drug: placebo

no O2

Outcome Measures

Primary Outcome Measures

skin grading evaluation of photodamage [8 weeks]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 60 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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).