A Pilot Study Testing the Efficacy of a Needling Device for the Treatment of Acne Scars

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Murad Alam, Northwestern University
ClinicalTrials.gov Identifier:
NCT00974870
First received: September 9, 2009
Last updated: September 14, 2012
Last verified: September 2012
  Purpose

The primary objective of this study is to determine the efficacy of a needling device for treatment of acne scars.


Condition Intervention
Acne Scars
Procedure: needling treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Split-face Randomized Controlled Trial to Assess the Efficacy of a Needling Device for the Treatment of Acne Scars

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • We will evaluate qualitatively and quantitatively the improvement of the subject's acne scars [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The tolerability of the treatment will be assessed [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Subject satisfaction will be determined [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Any adverse events of this treatment will be recorded. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: November 2009
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: needling treatment
Needling treatment applied to half of the face at each study visit
Procedure: needling treatment
Needling treatment applied to half of the face at each study visit
No Intervention: Control
No treatment applied to half of the face

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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00974870

Locations
United States, Illinois
Northwestern University Feinberg School of Medicine, Department of Dermatology
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Murad Alam, MD Northwestern University
  More Information

No publications provided

Responsible Party: Murad Alam, Professor in Dermatology, Otolaryngology- Head and Neck Surgery, and Surgery-Organ Transplantation, Northwestern University
ClinicalTrials.gov Identifier: NCT00974870     History of Changes
Other Study ID Numbers: STU15904
Study First Received: September 9, 2009
Last Updated: September 14, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Acne Vulgaris
Cicatrix
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014