Mild to Moderate AcneNCT01257555
Evaluation of a Photopneumatic System for the Treatment of Acne
An observational study of Mild to Moderate Acne, run by Solta Medical at 1 site in United States.
Trial summary
The purpose of the study is to evaluate the safety and efficacy of a photopneumatic therapy for the treatment of acne and concomitant symptoms associated with the disease, including erythema. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild to Moderate Acne
- What is being tested?
- Photopneumatic therapy
- Type of treatment
- Medical device
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Sep 2011
- Phase
- Observational
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: All genders and ethnic backgrounds. No subjects from vulnerable categories (i.e. minors, pregnant women, etc).
Who may be able to join
- Fitzpatrick skin type I-VI.
- Male or female.
- Subjects must be between 18 and 55 years of age.
- Subjects must have mild to moderate acne (defined as 15 or more inflammatory or non-inflammatory lesions).
- Subjects must read, understand, and sign the informed consent form.
- Subjects must be willing and able to comply with all follow-up requirements.
Who cannot join
- Subjects must not have active localized or systemic infections.
- Subjects must not have a compromised ability for wound healing, such as: malnutrition, steroid use, history of collagen vascular disease (e.g. lupus, scleroderma, history of keloid scar formation), atrophic dermatitis or immunologic abnormalities such as vitiligo.
- Subjects must not have received microdermabrasion within one (1) month prior to enrollment.
- Subjects must not have received immunosuppressive medication(s) one (1) month prior to enrollment.
- Subjects must not have received laser or light treatment within the last three (3) months.
- Subjects must not have received dermabrasion, TCA peel greater than 20%, botulinum toxin type A, dermal fillers, photodynamic therapy (PDT), or cosmetic surgery within the last six (6) months .
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- Subjects must not be currently taking or have used isotretinoin (e.g. Accutane) within six (6) months prior to enrollment.
- Subjects must agree to refrain from using cosmeceutical agents or topical agents during the course of the study, except as directed by study investigators.
- Subjects must not have had previous ablative laser treatment.
- Subjects must refrain from excessive sun exposure during participation in this study.
- Subjects must not have any condition that results in photosensitivity or be taking any medication containing aminolevulinic acid (E.g. Levulan).
- Subjects must not be a current or past smoker of cigarettes and/or cigars.
- Subjects must not be pregnant.
- Any condition or situation that would prevent the subject from safely completing all protocol requirements for participation.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to evaluate the safety and efficacy of a photopneumatic therapy for the treatment of acne and concomitant symptoms associated with the disease, including erythema.
Read the detailed description
The primary aims of the study will be to demonstrate the safety and efficacy of using a photopneumatic system for treatment of mild to moderate acne on the face or body - including neck, chest, and back - of up to 24 subjects. To support this clinical assessment, the affected areas to be treated will be documented at baseline, at each subsequent treatment visit (up to 6 treatments), and at one (1) month and three (3) months following final treatment.
- Conditions
- Mild to Moderate Acne
- Being tested
- Photopneumatic therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photopneumatic therapyDevice
Use of intense pulsed light (photo) in combination with vacuum technology (pneumatic) to treat mild to moderate acne.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Not described Receives: Device: Photopneumatic therapy |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild to Moderate AcneStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Solta Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01257555
- Sponsor's protocol ID
- 10-116-CF-I
- Status last verified
- Mar 2012
- First submitted
- 8 Dec 2010
- Last updated
- 26 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Photopneumatic System for the Treatment of Acne
- ClinicalTrials.gov ID
- NCT01257555
- Acronym / sponsor ID
- 10-116-CF-I
- Conditions
- Mild to Moderate Acne
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Solta MedicalIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 9 Dec 2010 (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.
The purpose of the study is to evaluate the safety and efficacy of a photopneumatic therapy for the treatment of acne and concomitant symptoms associated with the disease, including erythema.
Detailed description
The primary aims of the study will be to demonstrate the safety and efficacy of using a photopneumatic system for treatment of mild to moderate acne on the face or body - including neck, chest, and back - of up to 24 subjects. To support this clinical assessment, the affected areas to be treated will be documented at baseline, at each subsequent treatment visit (up to 6 treatments), and at one (1) month and three (3) months following final treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | – | Device: Photopneumatic therapy |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- All genders and ethnic backgrounds. No subjects from vulnerable categories (i.e. minors, pregnant women, etc).
Key inclusion criteria (6 listed)
- Fitzpatrick skin type I-VI.
- Male or female.
- Subjects must be between 18 and 55 years of age.
- Subjects must have mild to moderate acne (defined as 15 or more inflammatory or non-inflammatory lesions).
- Subjects must read, understand, and sign the informed consent form.
Key exclusion criteria (14 listed)
- Subjects must not have active localized or systemic infections.
- Subjects must not have a compromised ability for wound healing, such as: malnutrition, steroid use, history of collagen vascular disease (e.g. lupus, scleroderma, history of keloid scar formation), atrophic dermatitis or immunologic abnormalities such as vitiligo.
- Subjects must not have received microdermabrasion within one (1) month prior to enrollment.
- Subjects must not have received immunosuppressive medication(s) one (1) month prior to enrollment.
- Subjects must not have received laser or light treatment within the last three (3) months.
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 |
|---|---|---|
| Photopneumatic therapyUse of intense pulsed light (photo) in combination with vacuum technology (pneumatic) to treat mild to moderate acne. | Device | Treatment Group |
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 26 Mar 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mild to Moderate Acne, run by Solta Medical 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 6 inclusion and 14 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 26 Mar 2012. 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. 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 26 Mar 2012.