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

Primary Purpose

Rosacea, Acne Vulgaris, Atopic Dermatitis

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Topical oxygen

placebo

About this trial

This is an interventional treatment trial for Rosacea focused on measuring Topically dissolved oxygen, inflammatory cutaneous disease, rosacea, acne vulgaris, atopic dermatitis, seborrheic dermatitis, photodamage

Eligibility Criteria

25 Years - 60 Years (Adult)FemaleDoes not accept 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).

Sites / Locations

Dermatology Consultants Inc

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

Aria Regimens 0.5% conc

Aria Regimen (5 products) 0.25% conc

Aria Regimen Control without O2

Outcomes

Primary Outcome Measures

skin grading evaluation of photodamage

Secondary Outcome Measures

stratum corneum hydration (skin capacitance)

bioinstrumental assessment of skin "melanin" lightening, and lesional erythematous sites

bioinstrumental assessment of skin texture, scaliness (desquamation)

punch biopsy histopathologic examination (H&E, and immunohistochemistry for Aquaporin 3, and Filaggrin)

RT-PCR collagenase , and hypoxia-inducible factor-1 alpha

product performance

Full Information

NCT ID

NCT00991198

First Posted

October 6, 2009

Last Updated

June 6, 2011

Sponsor

Aria Aesthetics Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00991198

Brief Title

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

2. Study Status

Record Verification Date

June 2011

Overall Recruitment Status

Completed

Study Start Date

September 2009 (undefined)

Primary Completion Date

January 2010 (Actual)

Study Completion Date

January 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Aria Aesthetics Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rosacea, Acne Vulgaris, Atopic Dermatitis, Seborrheic Dermatitis

Keywords

Topically dissolved oxygen, inflammatory cutaneous disease, rosacea, acne vulgaris, atopic dermatitis, seborrheic dermatitis, photodamage

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

49 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Aria Regimens 0.5% conc

Arm Title

Arm Type

Experimental

Arm Description

Aria Regimen (5 products) 0.25% conc

Arm Title

Arm Type

Placebo Comparator

Arm Description

Aria Regimen Control without O2

Intervention Type

Drug

Intervention Name(s)

Topical oxygen

Intervention Description

0.5% concentration of Topical oxygen

Intervention Type

Drug

Intervention Name(s)

Topical oxygen

Intervention Description

0.25% concentration topical oxygen

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

no O2

Primary Outcome Measure Information:

Title

skin grading evaluation of photodamage

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

stratum corneum hydration (skin capacitance)

Time Frame

8 weeks

Title

bioinstrumental assessment of skin "melanin" lightening, and lesional erythematous sites

Time Frame

8 weeks

Title

bioinstrumental assessment of skin texture, scaliness (desquamation)

Time Frame

8 weeks

Title

punch biopsy histopathologic examination (H&E, and immunohistochemistry for Aquaporin 3, and Filaggrin)

Time Frame

8 weeks

Title

RT-PCR collagenase , and hypoxia-inducible factor-1 alpha

Time Frame

8 weeks

Title

product performance

Time Frame

8 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zoe D Draelos, MD

Organizational Affiliation

Dermatology Consultants Inc.

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dermatology Consultants Inc

City

High Point

State/Province

North Carolina

ZIP/Postal Code

27262

Country

United States

12. IPD Sharing Statement

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

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