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

NCT00974870 | Completed

• 1 other identifier: STU15904
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acne Scars

Outcome Measures

Primary Outcomes (1)

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

  6 months

Secondary Outcomes (3)

• The tolerability of the treatment will be assessed

  4 weeks

• Subject satisfaction will be determined

  6 months

• Any adverse events of this treatment will be recorded.

  6 months

Study Arms (2)

needling treatment

EXPERIMENTAL

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

Procedure: needling treatment

Control

NO INTERVENTION

No treatment applied to half of the face

Interventions

needling treatment PROCEDURE

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

needling treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University Feinberg School of Medicine, Department of Dermatology

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

• 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.

  PMID: 24919799 DERIVED

Study Officials

• Murad Alam, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Dermatology, Otolaryngology- Head and Neck Surgery, and Surgery-Organ Transplantation

Study Record Dates

• First Submitted: September 9, 2009
• First Posted: September 10, 2009
• Study Start: November 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: December 2, 2021

Record last verified: 2021-11

Locations

US (1)