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Completed

NCT Number: NCT00974870

A Pilot Study Testing 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.

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Key information

Conditions

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University Feinberg School of Medicine, Department of Dermatology

Chicago, Illinois, 60611, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

needling treatment

Procedure

Needling treatment applied to half of the face at each study visit

Primary outcomes

  1. We will evaluate qualitatively and quantitatively the improvement of the subject's acne scars

    Time frame: 6 months

Secondary outcomes

  1. The tolerability of the treatment will be assessed

    Time frame: 4 weeks

  2. Subject satisfaction will be determined

    Time frame: 6 months

  3. Any adverse events of this treatment will be recorded.

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

A Split-face Randomized Controlled Trial to Assess the Efficacy of a Needling Device for the Treatment of Acne Scars

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Sep 10, 2009
Registry last updated
Dec 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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