Acne ScarsNCT01221922
Laser Treatment of Acne Scars in Fitzpatrick Skin Types III-VI
A study testing RevLite Q-Switched Nd:YAG Laser in people with Acne Scars, run by ConBio, a Cynosure Company at 1 site in Thailand.
Trial summary
The purpose of this study is to evaluate the RevLite Q-Switched Neodymium: Yttrium-Aluminum-Garnet (Nd:YAG) Laser in the treatment of acne scars in darker skin types (Fitzpatrick Skin Types III, IV, V and VI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acne Scars
- What is being tested?
- RevLite Q-Switched Nd:YAG Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteThailand
- Study dates
- Oct 2010to Jan 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older with Fitzpatrick Skin Type III, IV, V or VI
- Evidence of atrophic scarring
Who cannot join
- Pregnancy, lactating or planning to become pregnant during the study
- History of cutaneous photosensitization, porphyria, and hypersensitivity to porphyrins or photodermatosis
- Any skin pathology or condition that could interfere with the evaluation or requires the use of interfering topical or systemic therapy
- Any condition which, in the investigator's opinion, would make it unsafe for the subject to participate
- Currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within 30 days prior to entering the study
- Subject is unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function
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- Subject may be unreliable for the study. This includes subjects who engage in excessive alcohol intake or drug abuse, or subjects who are unable to return for scheduled follow-up visits
- Use of oral or topical isotretinoin therapy within 6 months prior to enrollment. With the exception of isotretinoin, subjects will be allowed to continue their topical or oral acne medications during the trial
- Need to be exposed to artificial tanning devices or excessive sunlight during the trial
- Prior treatment with parenteral gold therapy
- Diabetes Type I or II, Lupus, Scleroderma or a similar immune system disorder
- Subject does not agree to refrain from any other type of facial skin resurfacing (e.g., microdermabrasion, laser or IPL treatment, chemical peel) or injected filler/other substances (e.g., Restylane, Botox) that might affect the treatment area for the duration of the study
- Underlying silicone or other nonabsorbable fillers in the treatment area or has had filler (e.g., collagen, fat) injections within the past 3 months
- History of keloidal scarring or nodulocystic acne
- Phenol or chemical peel or dermabrasion to the the treatment area within the past 6 months
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Kasemrad Aesthetic Center, Kasemrad Prachacheun Hospital
Bangkok
About this study
Official title: A Study of the RevLite Q-Switched Neodymium: Yttrium-Aluminum-Garnet (Nd:YAG) Laser for the Treatment of Acne Scars in Fitzpatrick Skin Types III-VI
The purpose of this study is to evaluate the RevLite Q-Switched Neodymium: Yttrium-Aluminum-Garnet (Nd:YAG) Laser in the treatment of acne scars in darker skin types (Fitzpatrick Skin Types III, IV, V and VI).
- Conditions
- Acne Scars
- Being tested
- RevLite Q-Switched Nd:YAG Laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RevLite Q-Switched Nd:YAG LaserDevice
Laser treatment once every 2 weeks for a total of 10 treatments.
| Study group | Role | What they receive |
|---|---|---|
| Acne treatment | Experimental | Treatment of acne scars Receives: Device: RevLite Q-Switched Nd:YAG Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Acne Scarring Classification
Measured: 3 Months post final treatment
Secondary outcomes (1)
Subject Satisfaction
5 point Likert scale
Measured: 3 Months post final treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne ScarsStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- ConBio, a Cynosure Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Niwat Polnikorn, MD, Principal investigator, Kasemrad Aesthetic Center, Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01221922
- Sponsor's protocol ID
- C67-10-A
- Status last verified
- Nov 2012
- First submitted
- 14 Oct 2010
- Last updated
- 28 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the RevLite Q-Switched Neodymium: Yttrium-Aluminum-Garnet (Nd:YAG) Laser for the Treatment of Acne Scars in Fitzpatrick Skin Types III-VI
- ClinicalTrials.gov ID
- NCT01221922
- Acronym / sponsor ID
- C67-10-A
- Conditions
- Acne Scars
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- ConBio, a Cynosure CompanyIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 18 Oct 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 this study is to evaluate the RevLite Q-Switched Neodymium: Yttrium-Aluminum-Garnet (Nd:YAG) Laser in the treatment of acne scars in darker skin types (Fitzpatrick Skin Types III, IV, V and VI).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acne treatment | Experimental | Device: RevLite Q-Switched Nd:YAG LaserTreatment of acne scars |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years or older with Fitzpatrick Skin Type III, IV, V or VI
- Evidence of atrophic scarring
Key exclusion criteria (15 listed)
- Pregnancy, lactating or planning to become pregnant during the study
- History of cutaneous photosensitization, porphyria, and hypersensitivity to porphyrins or photodermatosis
- Any skin pathology or condition that could interfere with the evaluation or requires the use of interfering topical or systemic therapy
- Any condition which, in the investigator's opinion, would make it unsafe for the subject to participate
- Currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within 30 days prior to entering the study
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 |
|---|---|---|
| RevLite Q-Switched Nd:YAG LaserLaser treatment once every 2 weeks for a total of 10 treatments. | Device | Acne treatment |
Primary outcome
Global Acne Scarring Classification
Time frame: 3 Months post final treatment
1 secondary outcome
Subject Satisfaction
Time frame: 3 Months post final treatment
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 28 Nov 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.
Niwat Polnikorn, MD principal investigator
Kasemrad Aesthetic Center, Thailand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RevLite Q-Switched Nd:YAG Laser in people with Acne Scars, run by ConBio, a Cynosure Company at 1 site in Thailand.
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 2 inclusion and 15 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 28 Nov 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 Thailand. 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.
What does the primary outcome measure?
Global Acne Scarring Classification (time frame: 3 Months post final treatment). 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 28 Nov 2012.