Clinical trial NCT00991198: The Role of Topically Dissolved Oxygen (TDO) to Ameliorate Signs of Photodamage
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rosacea
Acne Vulgaris
Atopic Dermatitis
Seborrheic Dermatitis
Keywords: Topically dissolved oxygen
inflammatory cutaneous disease
rosacea
acne vulgaris
atopic dermatitis
seborrheic dermatitis
photodamage
Lead sponsor: Aria Aesthetics Inc.
Sponsor class: INDUSTRY
First posted: 2009-10-07
Enrollment: 49
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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).

Primary outcomes:
measure: skin grading evaluation of photodamage
timeFrame: 8 weeks
Secondary outcomes:
measure: stratum corneum hydration (skin capacitance)
timeFrame: 8 weeks
measure: bioinstrumental assessment of skin "melanin" lightening, and lesional erythematous sites
timeFrame: 8 weeks
measure: bioinstrumental assessment of skin texture, scaliness (desquamation)
timeFrame: 8 weeks
measure: punch biopsy histopathologic examination (H&E, and immunohistochemistry for Aquaporin 3, and Filaggrin)
timeFrame: 8 weeks
measure: RT-PCR collagenase , and hypoxia-inducible factor-1 alpha
timeFrame: 8 weeks
measure: product performance
timeFrame: 8 weeks
Other outcomes:
Locations:
city: High Point
country: United States
facility: Dermatology Consultants Inc
state: North Carolina
Study officials:
affiliation: Dermatology Consultants Inc.
name: Zoe D Draelos, MD
role: PRINCIPAL_INVESTIGATOR
References: