Acne VulgarisNCT00714454
5% Sodium L-Ascorbyl-2-Phosphate Lotion for the Treatment of Acne Vulgaris
A study testing APS Topical Lotion in people with Acne Vulgaris, run by University of Miami at 1 site in United States.
Trial summary
12-week study to compare the efficacy and safety of a course of a twice daily treatment with APS in the form of a lotion to its vehicle for the treatment of acne. Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- APS Topical Lotion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Interventional
- 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 18 to 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject has read, understood, and signed appropriate informed consent, photo consent, and HIPAA consent in their own language.
- Subject has visible mild to severe acne, as assessed by the investigator.
- Subject will be available and willing to return for follow-up visits.
- Subject agrees not to use any other acne treatment products during the study.
- Subject is otherwise healthy, non-febrile, and is not suffering from an infection likely to require antibiotic therapy during the study period.
- Subject or guardian must be able to understand the new HIPAA regulations and sign the HIPAA form.
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- Subject is between the ages of 18 and 39.
- Subject agrees and understands that APS or its vehicle is to be applied to the subject twice daily for 12 weeks; no other topical or systemic medication affecting the course of acne and/or evaluability is to be used during the study.
- Subject agrees to use only the cleanser, moisturizer with sunscreen, and treatment provided by the study site for the duration of the study.
- Subject understands and agrees that he/she can not be treated with a systemic antibiotic for acne during the study.
- Subject agrees he/she will not use an acne topical treatment for two weeks prior to Day 0.
Who cannot join
- Subject or guardian has not signed informed consent, photo consent or HIPAA form.
- Subject is suffering from a condition likely to require medical attention, including administration of oral or systemic antibiotics, oral or systemic corticosteroids, or any other treatment which in the opinion of the investigator could influence the results of the study.
- Subject is pregnant or lactating.
- Subject is suffering from an abnormal skin condition not usually associated with acne.
- Subject will not be available for follow-up visits.
- Subject has been previously enrolled in any clinical study in which treatment was received within the past 30 days.
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- Subjects without comedones, papules, pustules, or nodules.
- Subject has a history of hypersensitivity to any other ingredients of the study lotion.
- Subject has a history of anaphylaxis.
- Subject is not able to avoid excessive sun exposure.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Miami Cosmetic Center
Miami Beach, Florida, 33140
About this study
Official title: 5% Sodium L-Ascorbyl-2-Phosphate Lotion for the Treatment of Acne Vulgaris: A Double-Blind, Placebo Controlled Trial
12-week study to compare the efficacy and safety of a course of a twice daily treatment with APS in the form of a lotion to its vehicle for the treatment of acne.
- Conditions
- Acne Vulgaris
- Being tested
- APS Topical Lotion, Placebo
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APS Topical LotionOther
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| APS | Active comparator | Not described Receives: Other: APS Topical Lotion |
| Vehicle | Placebo comparator | Not described Receives: Other: Placebo |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- 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 N/A
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Ikeno Clinic
- Investigators
- Heather Woolery-Lloyd, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00714454
- Sponsor's protocol ID
- 97269358-APS
- Status last verified
- Jul 2008
- First submitted
- 3 Jul 2008
- Last updated
- 14 Jul 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 5% Sodium L-Ascorbyl-2-Phosphate Lotion for the Treatment of Acne Vulgaris: A Double-Blind, Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT00714454
- Acronym / sponsor ID
- 97269358-APS
- Conditions
- Acne Vulgaris
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Ikeno Clinic
- First posted
- 14 Jul 2008 (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.
12-week study to compare the efficacy and safety of a course of a twice daily treatment with APS in the form of a lotion to its vehicle for the treatment of acne.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| APS | Active comparator | Other: APS Topical Lotion |
| Vehicle | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Subject has read, understood, and signed appropriate informed consent, photo consent, and HIPAA consent in their own language.
- Subject has visible mild to severe acne, as assessed by the investigator.
- Subject will be available and willing to return for follow-up visits.
- Subject agrees not to use any other acne treatment products during the study.
- Subject is otherwise healthy, non-febrile, and is not suffering from an infection likely to require antibiotic therapy during the study period.
Key exclusion criteria (10 listed)
- Subject or guardian has not signed informed consent, photo consent or HIPAA form.
- Subject is suffering from a condition likely to require medical attention, including administration of oral or systemic antibiotics, oral or systemic corticosteroids, or any other treatment which in the opinion of the investigator could influence the results of the study.
- Subject is pregnant or lactating.
- Subject is suffering from an abnormal skin condition not usually associated with acne.
- Subject will not be available for follow-up visits.
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 |
|---|---|---|
| APS Topical Lotion | Other | APS |
| Placebo | Other | Vehicle |
Primary outcome
Not reported in the source record.
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 14 Jul 2008.
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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.
Heather Woolery-Lloyd, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing APS Topical Lotion in people with Acne Vulgaris, run by University of Miami 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 11 inclusion and 10 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 14 Jul 2008. 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.
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.
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 14 Jul 2008.