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Trial record 40 of 83 for:    acne AND Acne Scars

Comparison of Treatments for Atrophic Acne Scars

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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

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.

Condition or disease Intervention/treatment Phase
Acne Scar Procedure: Laser Procedure: Microneedling Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Non-ablative Fractional Erbium Laser 1340nm and Microneedling for the Treatment of Atrophic Acne Scars: a Randomized Clinical Trial.
Study Start Date : December 2013
Estimated Primary Completion Date : August 2014
Estimated Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne Scars
Drug Information available for: Erbium

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 Name: 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 Name: Dermaroller




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Questionnaire to assess patients perceptions of the degree of improvement of scars with the treatment [ Time Frame: Six months after treatment ]
  2. Questionnaire to assess patients pain during treatment and recovery time [ Time Frame: Six months after treatment ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02025088


Contacts
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Contact: Thais H Cachafeiro, MD 55 51 3359-8571 thaishofmann@gmail.com
Contact: Gabriela F Escobar, MD 55 51 3359-8571 gabrieladermatologia@yahoo.com

Locations
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Brazil
Hospital de Clinicas de Porto Alegre Recruiting
Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
Contact: Thais H Cachafeiro, MD    55 51 3359-8571    thaishofmann@gmail.com   
Contact: Gabriela F Escobar, MD    55 51 3359-8571    gabrieladermatologia@yahoo.com   
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         
Sponsors and Collaborators
Thaís Hofmann Cachafeiro
Investigators
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Principal Investigator: Thais H Cachafeiro, MD Hospital de Clinicas de Porto Alegre

Publications:

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Responsible Party: Thaís Hofmann Cachafeiro, Dermatologist and student of post-graduation (masters degree), Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT02025088     History of Changes
Other Study ID Numbers: THC 13/14
First Posted: December 31, 2013    Key Record Dates
Last Update Posted: December 31, 2013
Last Verified: December 2013