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CompletedNCT00991198Updated Jun 8, 2011

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

A Phase 2 interventional study of Topical oxygen and Topical oxygen in Rosacea, Acne Vulgaris and Atopic Dermatitis, sponsored by Aria Aesthetics Inc.. Completed at 1 site in United States. Open to female participants aged 25 Years to 60 Years. Per ClinicalTrials.gov, last updated 2011-06-08.

Sponsored by Aria Aesthetics Inc. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
49
Allocation
Randomized
Ages
25 Years to 60 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Rosacea
  • Acne Vulgaris
  • Atopic Dermatitis
  • Seborrheic Dermatitis

Keywords

  • Topically dissolved oxygen
  • inflammatory cutaneous disease
  • rosacea
  • acne vulgaris
  • atopic dermatitis
  • seborrheic dermatitis
  • photodamage
03

In context

Dermatitis, Atopic

1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.

This study's enrollment of 49 is below the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.

Browse Dermatitis, Atopic studies →

Lead sponsor

This is the only study on the registry with Aria Aesthetics Inc. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 60 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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).
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
49 participants (actual)

Study arms

  • Experimental
    A

    Aria Regimens 0.5% conc

    Drug: Topical oxygen

  • Experimental
    B

    Aria Regimen (5 products) 0.25% conc

    Drug: Topical oxygen

  • Placebo comparator
    C

    Aria Regimen Control without O2

    Drug: placebo

Interventions

  • DrugTopical oxygen

    0.5% concentration of Topical oxygen

  • DrugTopical oxygen

    0.25% concentration topical oxygen

  • Drugplacebo

    no O2

06

What researchers measure

Primary outcomes

  1. skin grading evaluation of photodamage

    Time frame: 8 weeks

Secondary outcomes

  1. stratum corneum hydration (skin capacitance)

    Time frame: 8 weeks

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

    Time frame: 8 weeks

  3. bioinstrumental assessment of skin texture, scaliness (desquamation)

    Time frame: 8 weeks

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

    Time frame: 8 weeks

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

    Time frame: 8 weeks

  6. product performance

    Time frame: 8 weeks

07

Study locations

1 site
  • Dermatology Consultants Inc
    High Point, North Carolina 27262, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 8, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00991198
Lead sponsor
Aria Aesthetics Inc.
First posted
Oct 7, 2009
Start date
Sep 2009
Primary completion
Jan 2010
Completion
Jan 2010
Last update
Jun 8, 2011

Study contacts

Zoe D Draelos, MD
principal investigator · Dermatology Consultants Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2011. You cannot join it, but the record below documents what was studied.

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