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

Atopic Dermatitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00991198
• Other study ID #: IFLOTDO002
• Status: Completed
• Phase: Phase 2
• First received: October 6, 2009
• Last updated: June 6, 2011
• Start date: September 2009
• Est. completion date: January 2010

Study information

• Verified date: June 2011
• Source: Aria Aesthetics Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acne Vulgaris
• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Dermatitis, Seborrheic
• Eczema
• Rosacea
• Seborrheic Dermatitis

Intervention

Drug:
• Topical oxygen
0.5% concentration of Topical oxygen
• Topical oxygen
0.25% concentration topical oxygen
• placebo
no O2

Locations

Country	Name	City	State
United States	Dermatology Consultants Inc	High Point	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Aria Aesthetics Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	skin grading evaluation of photodamage		8 weeks	No
Secondary	stratum corneum hydration (skin capacitance)		8 weeks	No
Secondary	bioinstrumental assessment of skin "melanin" lightening, and lesional erythematous sites		8 weeks	No
Secondary	bioinstrumental assessment of skin texture, scaliness (desquamation)		8 weeks	No
Secondary	punch biopsy histopathologic examination (H&E, and immunohistochemistry for Aquaporin 3, and Filaggrin)		8 weeks	No
Secondary	RT-PCR collagenase , and hypoxia-inducible factor-1 alpha		8 weeks	No
Secondary	product performance		8 weeks	Yes