Comparison of Non-ablative Fractional Erbium Laser 1340nm and Microneedling for the Treatment of Atrophic Acne Scars: a Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Quantitative Global Grading System for Postacne Scarring
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of moderate or severe atrophic acne scars on the face
排除标准
- •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
结局指标
主要结局
Quantitative Global Grading System for Postacne Scarring
时间窗: 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.
次要结局
- 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)
研究者
Thaís Hofmann Cachafeiro
Dermatologist and student of post-graduation (masters degree)
Hospital de Clinicas de Porto Alegre