Comparison of Treatments for Atrophic Acne Scars

NCT02025088 | Unknown

• 1 other identifier: THC 13/14
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Acne; Scar

Outcome Measures

Primary Outcomes (1)

• Quantitative Global Grading System for Postacne Scarring

  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 Outcomes (2)

• Questionnaire to assess patients perceptions of the degree of improvement of scars with the treatment

  Six months after treatment

• Questionnaire to assess patients pain during treatment and recovery time

  Six months after treatment

Study Arms (2)

Laser

ACTIVE COMPARATOR

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

Microneedling

ACTIVE COMPARATOR

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

Interventions

Laser PROCEDURE

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.

Also known as: Non-ablative fractional erbium laser 1340 nm ProDeep

Laser

Microneedling PROCEDURE

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.

Also known as: Dermaroller

Microneedling

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Thaís Hofmann Cachafeiro: lead

Study Sites (1)

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

RECRUITING

Related Publications (10)

• Goodman GJ. Postacne scarring: a review of its pathophysiology and treatment. Dermatol Surg. 2000 Sep;26(9):857-71. doi: 10.1046/j.1524-4725.2000.99232.x.

  PMID: 10971560 BACKGROUND

• Grevelink JM, White VR. Concurrent use of laser skin resurfacing and punch excision in the treatment of facial acne scarring. Dermatol Surg. 1998 May;24(5):527-30. doi: 10.1111/j.1524-4725.1998.tb04201.x.

  PMID: 9598006 BACKGROUND

• Hu S, Hsiao WC, Chen MC, Huang YL, Chang SL, Shih PY, Gold MH. Ablative fractional erbium-doped yttrium aluminum garnet laser with coagulation mode for the treatment of atrophic acne scars in Asian skin. Dermatol Surg. 2011 Jul;37(7):939-44. doi: 10.1111/j.1524-4725.2011.02009.x. Epub 2011 May 25.

  PMID: 21615599 BACKGROUND

• Fernandes D. Minimally invasive percutaneous collagen induction. Oral Maxillofac Surg Clin North Am. 2005 Feb;17(1):51-63, vi. doi: 10.1016/j.coms.2004.09.004.

  PMID: 18088764 BACKGROUND

• Fife D. Practical evaluation and management of atrophic acne scars: tips for the general dermatologist. J Clin Aesthet Dermatol. 2011 Aug;4(8):50-7.

  PMID: 21909457 BACKGROUND

• Fabbrocini G, Annunziata MC, D'Arco V, De Vita V, Lodi G, Mauriello MC, Pastore F, Monfrecola G. Acne scars: pathogenesis, classification and treatment. Dermatol Res Pract. 2010;2010:893080. doi: 10.1155/2010/893080. Epub 2010 Oct 14.

  PMID: 20981308 BACKGROUND

• Sobanko JF, Alster TS. Management of acne scarring, part I: a comparative review of laser surgical approaches. Am J Clin Dermatol. 2012 Oct 1;13(5):319-30. doi: 10.2165/11598910-000000000-00000.

  PMID: 22612738 BACKGROUND

• Sardana K, Garg VK, Arora P, Khurana N. Histological validity and clinical evidence for use of fractional lasers for acne scars. J Cutan Aesthet Surg. 2012 Apr;5(2):75-90. doi: 10.4103/0974-2077.99431.

  PMID: 23060702 BACKGROUND

• Majid I. Microneedling therapy in atrophic facial scars: an objective assessment. J Cutan Aesthet Surg. 2009 Jan;2(1):26-30. doi: 10.4103/0974-2077.53096.

  PMID: 20300368 BACKGROUND

• Goodman GJ, Baron JA. Postacne scarring--a quantitative global scarring grading system. J Cosmet Dermatol. 2006 Mar;5(1):48-52. doi: 10.1111/j.1473-2165.2006.00222.x.

  PMID: 17173571 BACKGROUND

MeSH Terms

Conditions

Acne Vulgaris; Cicatrix

Interventions

Lasers; Percutaneous Collagen Induction

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Punctures; Rehabilitation

Study Officials

• Thais H Cachafeiro, MD

  Hospital de Clinicas de Porto Alegre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thais H Cachafeiro, MD

CONTACT

55 51 3359-8571; thaishofmann@gmail.com

Gabriela F Escobar, MD

CONTACT

55 51 3359-8571; gabrieladermatologia@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dermatologist and student of post-graduation (masters degree)

Study Record Dates

• First Submitted: December 29, 2013
• First Posted: December 31, 2013
• Study Start: December 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: November 1, 2014
• Last Updated: December 31, 2013

Record last verified: 2013-12

Locations

BR (1)