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

NCT ID: NCT00991198

Last Updated: 2011-06-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2010-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Rosacea Acne Vulgaris Atopic Dermatitis Seborrheic Dermatitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

A

Aria Regimens 0.5% conc

Group Type EXPERIMENTAL

Topical oxygen

Intervention Type DRUG

0.5% concentration of Topical oxygen

B

Aria Regimen (5 products) 0.25% conc

Group Type EXPERIMENTAL

Topical oxygen

Intervention Type DRUG

0.25% concentration topical oxygen

C

Aria Regimen Control without O2

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

no O2

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Topical oxygen

0.5% concentration of Topical oxygen

Intervention Type DRUG

Topical oxygen

0.25% concentration topical oxygen

Intervention Type DRUG

placebo

no O2

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).
Minimum Eligible Age

25 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Aria Aesthetics Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Aria Aesthetics, Inc.

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Zoe D Draelos, MD

Role: PRINCIPAL_INVESTIGATOR

Dermatology Consultants Inc.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Dermatology Consultants Inc

High Point, North Carolina, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IFLOTDO002

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Subantimicrobial Doxycycline in Acne
NCT05399290 COMPLETED PHASE4