Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparison of Treatments for Atrophic Acne Scars

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02025088
Recruitment Status : Unknown
Verified December 2013 by Thaís Hofmann Cachafeiro, Hospital de Clinicas de Porto Alegre.
Recruitment status was:  Recruiting
First Posted : December 31, 2013
Last Update Posted : December 31, 2013
Sponsor:
Information provided by (Responsible Party):
Thaís Hofmann Cachafeiro, Hospital de Clinicas de Porto Alegre

Tracking Information
First Submitted Date  ICMJE December 29, 2013
First Posted Date  ICMJE December 31, 2013
Last Update Posted Date December 31, 2013
Study Start Date  ICMJE December 2013
Estimated Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 29, 2013)
Quantitative Global Grading System for Postacne Scarring [ Time Frame: Before treatment, two months and six months after treatment ]
Goodman et al. in 2006, developed a scale of global severity of acne scarring, known as the Quantitative Global Scarring Grading System for Postacne Scarring. It relies on a scar count by type, calculating a score according to the number and severity of each type. The grading limits of this instrument are between 0-84 points and it seems to be an accurate and reproducible tool.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 29, 2013)
  • Questionnaire to assess patients perceptions of the degree of improvement of scars with the treatment [ Time Frame: Six months after treatment ]
  • Questionnaire to assess patients pain during treatment and recovery time [ Time Frame: Six months after treatment ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Treatments for Atrophic Acne Scars
Official Title  ICMJE Comparison of Non-ablative Fractional Erbium Laser 1340nm and Microneedling for the Treatment of Atrophic Acne Scars: a Randomized Clinical Trial.
Brief Summary Acne scars have high prevalence, significant impact on quality of life and are a therapeutic challenge for dermatologists. Previous studies have shown promising results for the treatment of acne scars with non-ablative fractional laser and microneedling, however there are no studies comparing the these techniques. Therefore, the objective of this study is to compare the effectiveness of treatment of atrophic acne scars on the face with non-ablative fractional erbium laser and microneedling.
Detailed Description

Acne is a multifactorial inflammatory dermatosis of the pilosebaceous unit, affecting up to 80 percent of teenagers and approximately 20 percent of adults. Scaring can occur early in acne development and may affect up to 95% of patients with this disease. However, the prevalence of acne scarring varies depending on the study.

Acne scars causes impairment of quality of life and has been described as a risk factor for suicide. Furthermore, it has also been linked to poor self esteem, depression, anxiety and lowered academic performance.

The most common type of acne scarring is atrophic, which includes: ice pick, rolling scars and boxcar scars.

Many treatments have been used for atrophic scars, including resurfacing procedures (chemical peels, dermabrasion and laser treatments), excisional procedures (punch excision, elevation by punch and elliptical excision of scars), application of fillers and microneedling, the latter since 2005, with satisfactory results and minimum time recovery.

Previous studies have shown promising results for the treatment of acne scars with non-ablative fractional laser and microneedling. Previous reports have also shown that the latter is associated with rapid healing period, a low complication rate and a low risk of post inflammatory hyperpigmentation.

However, there are no studies comparing the efficacy of microneedling with other techniques of resurfacing.

This study will be a single-blinded randomized clinical trial, comparing the application of non-ablative fractional erbium laser ProDeep 1340 nm and the technique of induction of neocollagenesis by microneedling. The primary objective of this study is to compare the effectiveness of treatment of atrophic acne scars on the face with non-ablative fractional erbium laser and microneedling. The secondary objectives are: assess the degree of satisfaction of participants with both techniques; check tolerability and incidence of adverse effects with both techniques; assess time needed for recovery and number of days absent from work or social activities after the procedures and evaluate the opinion and physical discomfort of each technique.

For each participant, a questionnaire will be filled out with the following information: gender, age, skin type, profession, current or previous history of smoking, use of medications, and presence of active acne. To assess the degree of scarring of the participants, the scale "Quantitative Global Scarring Grading System for Postacne Scarring" will be applied. After this evaluation, patients will be randomly allocated in each study groups (simple randomization). The randomization system was performed with the Microsoft Excel randomization program. Patients in both groups will undergo three sessions of laser treatment or three treatment sessions with microneedling, with an interval of six weeks between them.

Two independent dermatologists, blinded to the group of treatment which each patient belongs to, will apply the Quantitative Global Grading System for Postacne Scarring before treatment, two months and six months after treatment. There are no clinical signs or characteristics that enable the evaluators to identify which group each patient is allocated and patients will be instructed to not provide this information. Six months after completion of treatment, patients will answer a questionnaire to assess their perceptions of the degree of improvement of their scars, pain during treatment and recovery time, assigning values from 0 to 10, where 0 means maximum dissatisfaction and 10, maximum satisfaction.

To detect a difference of one standard deviation in the range between the groups (laser and microneedling), with a power of 90% and an α error ≤ 0.05, 23 patients are required for each group. Data will be inserted in Excel and then exported to SPSS v18.0 for statistical analysis. Quantitative variables will be analyzed by mean and standard deviation and the groups will be compared by Student's t test for independent samples. To compare the variation of the measurements between the groups throughout the sessions the analysis of variance for repeated measures will be used. For the analysis of interobserver agreement the intraclass correlation coefficient and the Bland - Altman method will be used.

This project was approved by the Committee of Research Ethics of our Hospital and all participants will sign an informed consent.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Acne
  • Scar
Intervention  ICMJE
  • Procedure: Laser
    Patients of this arm will undergo three sessions of laser treatment with an interval of six weeks between them. In each laser session, the non-ablative fractional erbium laser 1340 nm ProDeep (Etheria ® platform/Industra) with tip 100mtz/cm ² will be applied across the face, with a power of 120mJ/mtz time and pulse time of 5ms.
    Other Name: Non-ablative fractional erbium laser 1340 nm ProDeep
  • Procedure: Microneedling
    Patients in this arm will undergo three sessions with microneedling, with an interval of six weeks between them. In the microneedling sessions, the instrument contains 192 microneedles with 2 mm depth, which will be applied to the face in four different directions, making up about 20 movements of "coming and going" in each direction.
    Other Name: Dermaroller
Study Arms  ICMJE
  • Active Comparator: Laser
    In each laser session, the non-ablative fractional erbium laser 1340 nm ProDeep (Etheria ® platform/Industra) with tip 100mtz/cm ² will be applied across the face, with a power of 120mJ/mtz time and pulse time of 5ms.
    Intervention: Procedure: Laser
  • Active Comparator: Microneedling
    In the microneedling sessions, the instrument contains 192 microneedles with 2 mm depth, which will be applied to the face in four different directions, making up about 20 movements of "coming and going" in each direction.
    Intervention: Procedure: Microneedling
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 29, 2013)
23
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2014
Estimated Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Clinical diagnosis of moderate or severe atrophic acne scars on the face

Exclusion Criteria:

  • Previous history of photosensitivity or photosensitive diseases such as systemic lupus erythematosus or xeroderma pigmentosum
  • Previous history or presence of post inflammatory hyperpigmentation
  • Use of drugs that may induce hyperpigmentation, such as: amiodarone, clofazimine, minocycline or chloroquine
  • Presence of only "ice pick" scars
  • Pregnancy or lactation
  • Use of oral isotretinoin in the last six months
  • History of facial treatments with laser or surgery in the last three months
  • Herpetic infection, warts or any other active infection of the adjacent skin
  • Presence of skin cancer or actinic keratoses
  • Coagulopathies or anticoagulating therapy
  • Previous history or presence of hypertrophic scars or keloids
  • Patients being treated with chemotherapy, radiotherapy or corticosteroids at high doses
  • Diabetes mellitus
  • Inability to understand the goals and risks of treatment
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02025088
Other Study ID Numbers  ICMJE THC 13/14
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Thaís Hofmann Cachafeiro, Hospital de Clinicas de Porto Alegre
Study Sponsor  ICMJE Thaís Hofmann Cachafeiro
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Thais H Cachafeiro, MD Hospital de Clinicas de Porto Alegre
PRS Account Hospital de Clinicas de Porto Alegre
Verification Date December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP