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

Aria Aesthetics

Status and phase: Completed; Phase 2

Conditions: Atopic Dermatitis; Seborrheic Dermatitis; Acne Vulgaris; Rosacea

Treatments: Drug: placebo; Drug: Topical oxygen

Study type: Interventional

Funder types: Industry

Identifiers

NCT00991198

IFLOTDO002

Details and patient eligibility

About

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.

Enrollment: 49 patients

Sex: Female

Ages: 25 to 60 years old

Volunteers: No 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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49 participants in 3 patient groups, including a placebo group

A

Experimental group

Description:

Aria Regimens 0.5% conc

Treatment:

Drug: Topical oxygen

Drug: Topical oxygen

B

Experimental group

Description:

Aria Regimen (5 products) 0.25% conc

Treatment:

Drug: Topical oxygen

Drug: Topical oxygen

C

Placebo Comparator group

Description:

Aria Regimen Control without O2

Treatment:

Drug: placebo