RosaceaPhase 2NCT00991198
The Role of Topically Dissolved Oxygen (TDO) to Ameliorate Signs of Photodamage
A Phase 2 study testing Topical oxygen in people with Rosacea and Acne Vulgaris, run by Aria Aesthetics Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 25 to 60 years, women only
- Conditions the study is for
- Rosacea, Acne Vulgaris, Atopic Dermatitis
- What is being tested?
- Topical oxygen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Jan 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Dermatology Consultants Inc
High Point, North Carolina, 27262
About this study
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
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.
- Conditions
- Rosacea, Acne Vulgaris, Atopic Dermatitis, Seborrheic Dermatitis
- Being tested
- Topical oxygen, placebo
- Keywords
- Topically dissolved oxygen, inflammatory cutaneous disease, rosacea, acne vulgaris, atopic dermatitis, seborrheic dermatitis, photodamage
- Medical subject headings
- Rosacea, Acne Vulgaris, Dermatitis, Atopic, Dermatitis, Seborrheic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical oxygenDrug
0.5% concentration of Topical oxygen
Topical oxygenDrug
0.25% concentration topical oxygen
placeboDrug
no O2
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Aria Regimens 0.5% conc Receives: Drug: Topical oxygen |
| B | Experimental | Aria Regimen (5 products) 0.25% conc Receives: Drug: Topical oxygen |
| C | Placebo comparator | Aria Regimen Control without O2 Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
skin grading evaluation of photodamage
Measured: 8 weeks
Secondary outcomes (6)
stratum corneum hydration (skin capacitance)
Measured: 8 weeks
bioinstrumental assessment of skin "melanin" lightening, and lesional erythematous sites
Measured: 8 weeks
bioinstrumental assessment of skin texture, scaliness (desquamation)
Measured: 8 weeks
punch biopsy histopathologic examination (H&E, and immunohistochemistry for Aquaporin 3, and Filaggrin)
Measured: 8 weeks
RT-PCR collagenase , and hypoxia-inducible factor-1 alpha
Measured: 8 weeks
product performance
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2009 (estimated)
- Study startSep 2009
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RosaceaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aria Aesthetics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Zoe D Draelos, MD, Principal investigator, Dermatology Consultants Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00991198
- Sponsor's protocol ID
- IFLOTDO002
- Status last verified
- Jun 2011
- First submitted
- 6 Oct 2009
- Last updated
- 8 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00991198
- Acronym / sponsor ID
- IFLOTDO002
- Conditions
- Rosacea, Acne Vulgaris, Atopic Dermatitis, Seborrheic Dermatitis
- Keywords
- Topically dissolved oxygen, inflammatory cutaneous disease, rosacea, acne vulgaris, atopic dermatitis, seborrheic dermatitis, photodamage
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Aria Aesthetics Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 7 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Topical oxygenAria Regimens 0.5% conc |
| B | Experimental | Drug: Topical oxygenAria Regimen (5 products) 0.25% conc |
| C | Placebo comparator | Drug: placeboAria Regimen Control without O2 |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topical oxygen0.5% concentration of Topical oxygen | Drug | A |
| Topical oxygen0.25% concentration topical oxygen | Drug | B |
| placebono O2 | Drug | C |
Primary outcome
skin grading evaluation of photodamage
Time frame: 8 weeks
6 secondary outcomes
stratum corneum hydration (skin capacitance)
Time frame: 8 weeks
bioinstrumental assessment of skin "melanin" lightening, and lesional erythematous sites
Time frame: 8 weeks
bioinstrumental assessment of skin texture, scaliness (desquamation)
Time frame: 8 weeks
punch biopsy histopathologic examination (H&E, and immunohistochemistry for Aquaporin 3, and Filaggrin)
Time frame: 8 weeks
RT-PCR collagenase , and hypoxia-inducible factor-1 alpha
Time frame: 8 weeks
product performance
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zoe D Draelos, MD principal investigator
Dermatology Consultants Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Topical oxygen in people with Rosacea and Acne Vulgaris, run by Aria Aesthetics Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
skin grading evaluation of photodamage (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2011.