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

Primary Purpose

Acne Scars

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

needling treatment

About this trial

This is an interventional treatment trial for Acne Scars

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Northwestern University Feinberg School of Medicine, Department of Dermatology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

needling treatment

Control

Arm Description

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

No treatment applied to half of the face

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

The tolerability of the treatment will be assessed

Subject satisfaction will be determined

Any adverse events of this treatment will be recorded.

Full Information

NCT ID

NCT00974870

First Posted

September 9, 2009

Last Updated

November 30, 2021

Sponsor

Northwestern University

1. Study Identification

Unique Protocol Identification Number

NCT00974870

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Completed

Study Start Date

November 2009 (undefined)

Primary Completion Date

July 2010 (Actual)

Study Completion Date

July 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Northwestern University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acne Scars

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

needling treatment

Arm Type

Experimental

Arm Description

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

Arm Title

Control

Arm Type

No Intervention

Arm Description

No treatment applied to half of the face

Intervention Type

Procedure

Intervention Name(s)

needling treatment

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

6 months

Secondary Outcome Measure Information:

Title

The tolerability of the treatment will be assessed

Time Frame

4 weeks

Title

Subject satisfaction will be determined

Time Frame

6 months

Title

Any adverse events of this treatment will be recorded.

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Murad Alam, MD

Organizational Affiliation

Northwestern University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Northwestern University Feinberg School of Medicine, Department of Dermatology

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

24919799

Citation

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.

Results Reference

derived

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

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