Comparison of Treatments for Atrophic Acne Scars

December 29, 2013 updated by: Thaís Hofmann Cachafeiro

Comparison of Non-ablative Fractional Erbium Laser 1340nm and Microneedling for the Treatment of Atrophic Acne Scars: a Randomized Clinical Trial.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

23

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
        • Recruiting
        • Hospital de Clínicas de Porto Alegre
        • Contact:
        • Contact:
        • Principal Investigator:
          • Thais H Cachafeiro, MD
        • Sub-Investigator:
          • Gabriela F Escobar, MD
        • Sub-Investigator:
          • Gabriela Maldonado, MD
        • Sub-Investigator:
          • Tania F Cestari, MD
        • Sub-Investigator:
          • Oly C Corleta, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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 Names:
  • Non-ablative fractional erbium laser 1340 nm ProDeep
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.
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 Names:
  • Dermaroller

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Before treatment, two months and six months after treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Questionnaire to assess patients perceptions of the degree of improvement of scars with the treatment
Time Frame: Six months after treatment
Six months after treatment
Questionnaire to assess patients pain during treatment and recovery time
Time Frame: Six months after treatment
Six months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thaís Hofmann Cachafeiro

Investigators

  • Principal Investigator: Thais H Cachafeiro, MD, Hospital de Clínicas de Porto Alegre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Anticipated)

August 1, 2014

Study Completion (Anticipated)

November 1, 2014

Study Registration Dates

First Submitted

December 29, 2013

First Submitted That Met QC Criteria

December 29, 2013

First Posted (Estimate)

December 31, 2013

Study Record Updates

Last Update Posted (Estimate)

December 31, 2013

Last Update Submitted That Met QC Criteria

December 29, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • THC 13/14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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