Acne ScarringNCT00641420
Safety and Efficacy of 1550nm Fractional Laser Treatment for Acne Scars in Fitzpatrick Type IV-VI Skin
A study testing Fractionated Laser Resurfacing in people with Acne Scarring, run by Henry Ford Health System at 1 site in United States.
Trial summary
Fractionated laser resurfacing is commonly used as a treatment for acne scarring in fair skinned individuals. This study aims to test the efficacy and safety in darker skin types. Patients are randomized to either the 10mJ 40mJ dosages and receive a total of five treatments at 17% one month apart. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne Scarring
- What is being tested?
- Fractionated Laser Resurfacing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Sep 2008
- 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 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female voluntary patients between the ages of 18 and 59 with Fitzpatrick skin type IV-VI as verified by one of the investigators
- Patients with clinical diagnosis of ice pick, rolling, or boxcar type ane scarring
- Patients able to follow instructions
- If patient has a history of cold sores (herpes labialis) they must be willing to take prophylactic valtrex
- Written informed consent from the patients (Appendix II)
Who cannot join
- Children (less than 18 years old)
- Pregnant or lactating women
- Personal history of keloids or hypertrophic scarring
- Active acne requiring topical or oral therapy
- Accutane or other oral retinoid in past year
- Patients with a known allergy to lidocaine
Show all 12Show fewer
- Allergy to valacyclovir in a patient that needs prophylaxis
- Patients with an unstable or non controlled underlying medical problem
- Patients who are not able to follow instructions
- Patients who have participated in a study within the 3 months prior to study entry
- Patients who refuse to give written informed consent
- Patients with a history of a pigmentary abnormality
Trial locations and contacts
1 site in 1 country.
About this study
Fractionated laser resurfacing is commonly used as a treatment for acne scarring in fair skinned individuals. This study aims to test the efficacy and safety in darker skin types. Patients are randomized to either the 10mJ 40mJ dosages and receive a total of five treatments at 17% one month apart. Improvement is judged by a dermatologist as 0-25%, 25-50%, 50-75% or 75-100%. Side effects such as pigmentary abnormalities and pain are also evaluated.
Read the detailed description
Background: Ablative resurfacing lasers are effective for treatment of acne scars, but they have a high risk of complications. Fractional lasers have less severe side effects but more moderate efficacy than ablative devices. Studies were performed in individuals with Fitzpatrick skin type I to VI.
Objective: To determine the efficacy and safety of an erbium 1,550-nm fractional laser in the treatment of facial acne scars in Fitzpatrick skin types IV to VI.
Methods: We conducted a prospective, single-blind, randomized trial in patients with acne scars (n=15), skin type IV to VI, with a 1,550-nm erbium fractionated laser. Patients were divided into two groups; one was treated with 10 mJ and the other with 40 mJ. Five monthly laser sessions were performed. A patient questionnaire was distributed.
- Conditions
- Acne Scarring
- Being tested
- Fractionated Laser Resurfacing
- Keywords
- Acne scarring, Post inflammatory hyperpigmentation
- Medical subject headings
- Hyperpigmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fractionated Laser ResurfacingProcedure or surgery
Also called Fractionated Laser: FRAXEL
| Study group | Role | What they receive |
|---|---|---|
| Fractional Laser 10mJ | Experimental | Patients receive fractional laser resurfacing to 17% of the face five times one month apart at 10mJ. Receives: Procedure: Fractionated Laser Resurfacing |
| Fractional Laser 40mJ | Experimental | Patients receive fractional laser resurfacing to 17% of the face five times one month apart at 40mJ. Receives: Procedure: Fractionated Laser Resurfacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in acne scarring.
Blinded evaluators will score improvement of acne via photographs using a quartile grading scale (0 = no improvement, 1 = minor improvement [1-25%], 2 =moderate improvement [26-50%], 3 =marked improvement [51-75%], 4 = very significant improvement [76-100%]).
Measured: 6 months
Secondary outcomes (2)
Dyspigmentation
dyspigmentation will be assessed separately from acne scarring via photographs with blinded evaluators on a scale of 1- 3. 1 (minimal amount of hyperpigmentation), 2 (moderate hyperpigmentation) and 3 (severe amount of hyperpigmentation) depending on the degree of hyperpigmentation compared with their baseline photo.
Measured: 6 months
Pain with treatment
subjects will report any pain with treatment on a 0-10 scale, with zero indicating no pain and 10 indicating the worst pain
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2008 (estimated)
- Study startSep 2007
- Primary completionAug 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne ScarringStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David M. Ozog, Henry Ford Health System
- Investigators
- David M Ozog, MD, Principal investigator, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00641420
- Sponsor's protocol ID
- HenryFord4447
- Status last verified
- Mar 2022
- First submitted
- 17 Mar 2008
- Last updated
- 15 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of 1550nm Fractional Laser Treatment for Acne Scars in Fitzpatrick Type IV-VI Skin
- ClinicalTrials.gov ID
- NCT00641420
- Acronym / sponsor ID
- HenryFord4447
- Conditions
- Acne Scarring
- Keywords
- Acne scarring, Post inflammatory hyperpigmentation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 24 Mar 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.
Fractionated laser resurfacing is commonly used as a treatment for acne scarring in fair skinned individuals. This study aims to test the efficacy and safety in darker skin types. Patients are randomized to either the 10mJ 40mJ dosages and receive a total of five treatments at 17% one month apart. Improvement is judged by a dermatologist as 0-25%, 25-50%, 50-75% or 75-100%. Side effects such as pigmentary abnormalities and pain are also evaluated.
Detailed description
Background: Ablative resurfacing lasers are effective for treatment of acne scars, but they have a high risk of complications. Fractional lasers have less severe side effects but more moderate efficacy than ablative devices. Studies were performed in individuals with Fitzpatrick skin type I to VI.
Objective: To determine the efficacy and safety of an erbium 1,550-nm fractional laser in the treatment of facial acne scars in Fitzpatrick skin types IV to VI.
Methods: We conducted a prospective, single-blind, randomized trial in patients with acne scars (n=15), skin type IV to VI, with a 1,550-nm erbium fractionated laser. Patients were divided into two groups; one was treated with 10 mJ and the other with 40 mJ. Five monthly laser sessions were performed. A patient questionnaire was distributed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fractional Laser 10mJ | Experimental | Procedure: Fractionated Laser ResurfacingPatients receive fractional laser resurfacing to 17% of the face five times one month apart at 10mJ. |
| Fractional Laser 40mJ | Experimental | Procedure: Fractionated Laser ResurfacingPatients receive fractional laser resurfacing to 17% of the face five times one month apart at 40mJ. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male or female voluntary patients between the ages of 18 and 59 with Fitzpatrick skin type IV-VI as verified by one of the investigators
- Patients with clinical diagnosis of ice pick, rolling, or boxcar type ane scarring
- Patients able to follow instructions
- If patient has a history of cold sores (herpes labialis) they must be willing to take prophylactic valtrex
- Written informed consent from the patients (Appendix II)
Key exclusion criteria (12 listed)
- Children (less than 18 years old)
- Pregnant or lactating women
- Personal history of keloids or hypertrophic scarring
- Active acne requiring topical or oral therapy
- Accutane or other oral retinoid in past year
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 |
|---|---|---|
| Fractionated Laser ResurfacingAlso: Fractionated Laser: FRAXEL | Procedure or surgery | Fractional Laser 10mJ, Fractional Laser 40mJ |
Primary outcome
Improvement in acne scarring.
Time frame: 6 months
Blinded evaluators will score improvement of acne via photographs using a quartile grading scale (0 = no improvement, 1 = minor improvement [1-25%], 2 =moderate improvement [26-50%], 3 =marked improvement [51-75%], 4 = very significant improvement [76-100%]).
2 secondary outcomes
Dyspigmentation
Time frame: 6 months
Pain with treatment
Time frame: 5 months
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 15 Mar 2022.
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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.
David M Ozog, MD principal investigator
Henry Ford Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fractionated Laser Resurfacing in people with Acne Scarring, run by Henry Ford Health System 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 5 inclusion and 12 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 15 Mar 2022. 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.
What does the primary outcome measure?
Improvement in acne scarring. (time frame: 6 months). 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 15 Mar 2022.