Acne ScarsNCT00974870
A Pilot Study Testing the Efficacy of a Needling Device for the Treatment of Acne Scars
A study testing needling treatment in people with Acne Scars, run by Northwestern University at 1 site in United States.
Trial summary
The primary objective of this study is to determine the efficacy of a needling device for treatment of acne scars. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne Scars
- What is being tested?
- needling treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Jul 2010
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ages 18-70 years old
- Subjects in general good health
- The subject has the willingness and the ability to understand and provide informed consent for the use of their tissue and communicate with the investigator
- Global Acne Scarring Classification grade 2-41 (Appendix II)
- Subject has at least two areas of acne scaring on the face (with at least 2 acne scars in each) that are at least 2 cm apart
Who cannot join
- Pregnancy and lactation
- Subjects with history of keloid or hypertrophic scars
- Subjects with active skin disease (other than mild acne) or skin infection in the treatment area
- Subjects with an active systematic or local skin disease that is likely to alter wound healing
- Subjects who have undergone in the past 6 months or planning to undergo in the next 6 months the following cosmetic treatments in the acne scar area
- Injectable permanent filler
Show all 11Show fewer
- Ablative laser treatment
- Subjects taking the following prescription medications:
- Accutane or other retinoids within the past 12 months
- Anticoagulant (warfarin)
- Subjects who allergic to lidocaine and prilocaine
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University Feinberg School of Medicine, Department of Dermatology
Chicago, Illinois, 60611
About this study
Official title: A Split-face Randomized Controlled Trial to Assess the Efficacy of a Needling Device for the Treatment of Acne Scars
The primary objective of this study is to determine the efficacy of a needling device for treatment of acne scars.
Read the detailed description
We are investigating a needled micro-roller for use in improving the appearance of acne scars. The study is being conducted under the direction of Dr. Murad Alam of Northwestern University, Department of Dermatology.
The needles on the micro-roller are designed to create small holes in the top and mid layers of skin in order to induce the formation of more collagen, which would in turn help improve the appearance of acne scars. To qualify for the study, you must have at least 2 large areas of the face with acne scars.
The study is designed such that one part of your face, which has acne scars, will be treated with the device on 3 separate occasions, spaced 2 weeks apart at our clinic in Chicago at Northwestern. We would also ask you to return at 3 months and at 6 months to have photographs taken.
If you are interested in participating, we would like to get you involved as soon as possible
- Conditions
- Acne Scars
- Being tested
- needling treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
needling treatmentProcedure or surgery
Needling treatment applied to half of the face at each study visit
| Study group | Role | What they receive |
|---|---|---|
| needling treatment | Experimental | Needling treatment applied to half of the face at each study visit Receives: Procedure: needling treatment |
| Control | No intervention | No treatment applied to half of the face |
What is being measured
The primary outcome is the main question the study is designed to answer.
We will evaluate qualitatively and quantitatively the improvement of the subject's acne scars
Measured: 6 months
Secondary outcomes (3)
The tolerability of the treatment will be assessed
Measured: 4 weeks
Subject satisfaction will be determined
Measured: 6 months
Any adverse events of this treatment will be recorded.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2009 (estimated)
- Study startNov 2009
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acne ScarsStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murad Alam, Northwestern University
- Investigators
- Murad Alam, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00974870
- Sponsor's protocol ID
- STU15904
- Status last verified
- Nov 2021
- First submitted
- 9 Sep 2009
- Last updated
- 2 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Alam M, Han S, Pongprutthipan M, Disphanurat W, Kakar R, Nodzenski M, Pace N, Kim N, Yoo S, Veledar E, Poon E, West DP. Efficacy of a needling device for the treatment of acne scars: a randomized clinical trial. JAMA Dermatol. 2014 Aug;150(8):844-9. doi: 10.1001/jamadermatol.2013.8687.
PubMed 24919799
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Split-face Randomized Controlled Trial to Assess the Efficacy of a Needling Device for the Treatment of Acne Scars
- ClinicalTrials.gov ID
- NCT00974870
- Acronym / sponsor ID
- STU15904
- Conditions
- Acne Scars
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 10 Sep 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.
The primary objective of this study is to determine the efficacy of a needling device for treatment of acne scars.
Detailed description
We are investigating a needled micro-roller for use in improving the appearance of acne scars. The study is being conducted under the direction of Dr. Murad Alam of Northwestern University, Department of Dermatology.
The needles on the micro-roller are designed to create small holes in the top and mid layers of skin in order to induce the formation of more collagen, which would in turn help improve the appearance of acne scars. To qualify for the study, you must have at least 2 large areas of the face with acne scars.
The study is designed such that one part of your face, which has acne scars, will be treated with the device on 3 separate occasions, spaced 2 weeks apart at our clinic in Chicago at Northwestern. We would also ask you to return at 3 months and at 6 months to have photographs taken.
If you are interested in participating, we would like to get you involved as soon as possible
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| needling treatment | Experimental | Procedure: needling treatmentNeedling treatment applied to half of the face at each study visit |
| Control | No intervention | –No treatment applied to half of the face |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Ages 18-70 years old
- Subjects in general good health
- The subject has the willingness and the ability to understand and provide informed consent for the use of their tissue and communicate with the investigator
- Global Acne Scarring Classification grade 2-41 (Appendix II)
- Subject has at least two areas of acne scaring on the face (with at least 2 acne scars in each) that are at least 2 cm apart
Key exclusion criteria (11 listed)
- Pregnancy and lactation
- Subjects with history of keloid or hypertrophic scars
- Subjects with active skin disease (other than mild acne) or skin infection in the treatment area
- Subjects with an active systematic or local skin disease that is likely to alter wound healing
- Subjects who have undergone in the past 6 months or planning to undergo in the next 6 months the following cosmetic treatments in the acne scar area
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 |
|---|---|---|
| needling treatmentNeedling treatment applied to half of the face at each study visit | Procedure or surgery | needling treatment |
Primary outcome
We will evaluate qualitatively and quantitatively the improvement of the subject's acne scars
Time frame: 6 months
3 secondary outcomes
The tolerability of the treatment will be assessed
Time frame: 4 weeks
Subject satisfaction will be determined
Time frame: 6 months
Any adverse events of this treatment will be recorded.
Time frame: 6 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 2 Dec 2021.
- Derived from this study: PubMed 24919799Alam M, Han S, Pongprutthipan M, Disphanurat W, Kakar R, Nodzenski M, Pace N, Kim N, Yoo S, Veledar E, Poon E, West DP. Efficacy of a needling device for the treatment of acne scars: a randomized clinical trial. JAMA Dermatol. 2014 Aug;150(8):844-9. doi: 10.1001/jamadermatol.2013.8687.
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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.
Murad Alam, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing needling treatment in people with Acne Scars, run by Northwestern University 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 11 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 2 Dec 2021. 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?
We will evaluate qualitatively and quantitatively the improvement of the subject's acne scars (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00974870, which also lists 1 linked publication.
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 2 Dec 2021.