The Role of Topically Dissolved Oxygen (TDO) to Ameliorate Signs of Photodamage - Full Text View

Sponsor:	Aria Aesthetics Inc.
Information provided by:	Aria Aesthetics Inc.
ClinicalTrials.gov Identifier:	NCT00991198

Purpose

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	Intervention	Phase
Rosacea Acne Vulgaris Atopic Dermatitis Seborrheic Dermatitis	Drug: Topical oxygen Drug: placebo	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Acne Rosacea Skin Conditions

U.S. FDA Resources

Further study details as provided by Aria Aesthetics Inc.:

Primary Outcome Measures:

skin grading evaluation of photodamage [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

stratum corneum hydration (skin capacitance) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
bioinstrumental assessment of skin "melanin" lightening, and lesional erythematous sites [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
bioinstrumental assessment of skin texture, scaliness (desquamation) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
punch biopsy histopathologic examination (H&E, and immunohistochemistry for Aquaporin 3, and Filaggrin) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
RT-PCR collagenase , and hypoxia-inducible factor-1 alpha [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
product performance [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	45
Study Start Date:	September 2009
Estimated Study Completion Date:	November 2009
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

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

Eligibility

Ages Eligible for Study:	25 Years to 60 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00991198

Contacts

Contact: Zoe D Draelos, MD	336-841-2040
Contact: Lawrence Rheins, PhD	480-305-2059 ext 5070

Locations

United States, North Carolina
Dermatology Consultants Inc	Recruiting
High Point, North Carolina, United States, 27262
Contact: Zoe Draelos, MD 336-841-2040
Principal Investigator: Zoe D Draelos, MD

Sponsors and Collaborators

Aria Aesthetics Inc.

Investigators

Principal Investigator:

Zoe D Draelos, MD

Dermatology Consultants Inc.

More Information

No publications provided

Responsible Party:	Aria Aesthetics, Inc. ( Larry Rheins, PhD/President )
Study ID Numbers:	IFLOTDO002
Study First Received:	October 6, 2009
Last Updated:	October 6, 2009
ClinicalTrials.gov Identifier:	NCT00991198 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Aria Aesthetics Inc.:

Topically dissolved oxygen
inflammatory cutaneous disease
rosacea
acne vulgaris

atopic dermatitis
seborrheic dermatitis
photodamage

Additional relevant MeSH terms:

Dermatitis, Atopic
Facial Dermatoses
Immune System Diseases
Skin Diseases
Sebaceous Gland Diseases
Acne Vulgaris
Dermatitis, Seborrheic
Rosacea

Hypersensitivity
Genetic Diseases, Inborn
Acneiform Eruptions
Hypersensitivity, Immediate
Skin Diseases, Eczematous
Skin Diseases, Papulosquamous
Skin Diseases, Genetic
Dermatitis

ClinicalTrials.gov processed this record on November 20, 2009