A Pilot Study Testing the Efficacy of a Needling Device for the Treatment of Acne Scars
NCT ID: NCT00974870
Last Updated: 2021-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
20 participants
INTERVENTIONAL
2009-11-30
2010-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
needling treatment
Needling treatment applied to half of the face at each study visit
needling treatment
Needling treatment applied to half of the face at each study visit
Control
No treatment applied to half of the face
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
needling treatment
Needling treatment applied to half of the face at each study visit
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Northwestern University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Murad Alam
Professor in Dermatology, Otolaryngology- Head and Neck Surgery, and Surgery-Organ Transplantation
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Murad Alam, MD
Role: PRINCIPAL_INVESTIGATOR
Northwestern University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Northwestern University Feinberg School of Medicine, Department of Dermatology
Chicago, Illinois, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
STU15904
Identifier Type: -
Identifier Source: org_study_id