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

June 6, 2011 updated by: Aria Aesthetics Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • High Point, North Carolina, United States, 27262
        • Dermatology Consultants Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
skin grading evaluation of photodamage
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
stratum corneum hydration (skin capacitance)
Time Frame: 8 weeks
8 weeks
bioinstrumental assessment of skin "melanin" lightening, and lesional erythematous sites
Time Frame: 8 weeks
8 weeks
bioinstrumental assessment of skin texture, scaliness (desquamation)
Time Frame: 8 weeks
8 weeks
punch biopsy histopathologic examination (H&E, and immunohistochemistry for Aquaporin 3, and Filaggrin)
Time Frame: 8 weeks
8 weeks
RT-PCR collagenase , and hypoxia-inducible factor-1 alpha
Time Frame: 8 weeks
8 weeks
product performance
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aria Aesthetics Inc.

Investigators

  • Principal Investigator: Zoe D Draelos, MD, Dermatology Consultants Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

October 6, 2009

First Submitted That Met QC Criteria

October 6, 2009

First Posted (Estimate)

October 7, 2009

Study Record Updates

Last Update Posted (Estimate)

June 8, 2011

Last Update Submitted That Met QC Criteria

June 6, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IFLOTDO002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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