Efficacy of Combination Therapy With Microneedling and the Universal Peel For Acne Scarring in Skin Types III-VI
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Improvement in the appearance of acne scarring as measured by The Goodman and Baron Grading Scale.
研究概览
简要总结
Acne is a prevalent disorder mostly witnessed in adolescents, but can be seen in adults. Early treatment is imperative to reduce acne scarring which can appear with atrophic lesions, and depending on the skin type, significant erythema (redness) or post-inflammatory hyperpigmentation. A multi-modality approach to treatment is necessary when dealing with the aforementioned types of lesions. Pharmacologic management is essential, but safe procedural therapies are also necessary specifically with darker skinned individuals.
Percutaneous collagen induction therapy (PCIT) is a non-invasive treatment achieved by using a micro-needling device, which is safe and effective in causing "micro-wounds" into the dermis thereby initiating wound healing followed by collagen production. This is an ideal treatment for acne scarring, re-texturizing of the skin, and hyperpigmentation for all skin types . Currently there are very few studies evaluating the safety and efficacy of microneedling and chemical peels in skin types III-VI.
The aim of this study is to evaluate the effects of the combination of microneedling and chemical peel for the treatment of acne scars in skin types III-VI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject > 18 and < 60 years of age.
- •Subject has skin type III, IV, V, or VI as defined by the Fitzpatrick Classification Scale.
- •Subject has acne scarring as defined by the Goodman and Baron Grading System.
排除标准
- •Subject currently has moderate to severe acne on the face.
- •Subject has an active infection.
- •Subject is pregnant or lactating.
- •Subject has a history of a bleeding disorder.
- •Subject is taking an anti-coagulant.
- •Subject has a history of keloidal tendency.
- •Subject has received ablative or non-ablative laser treatments in the previous 6 months.
- •Subject has taken Accutane within the previous 3 months.
研究组 & 干预措施
Microneedling Plus Universal Peel
(1) Microneedling treatment by the MicroPen with a Post-Microneedling Skin Care Regimen and the (2) Universal Peel by Topix with a Post-Universal Peel Skin Care Regimen will both be performed on a monthly basis for a total of three treatment sessions each.
Microneedling will be done on Study Weeks 1, 5, and 9. Universal Peel will be done on Study Weeks 3, 7, and 11.
干预措施: Universal Peel (Drug)
Microneedling Plus Universal Peel
(1) Microneedling treatment by the MicroPen with a Post-Microneedling Skin Care Regimen and the (2) Universal Peel by Topix with a Post-Universal Peel Skin Care Regimen will both be performed on a monthly basis for a total of three treatment sessions each.
Microneedling will be done on Study Weeks 1, 5, and 9. Universal Peel will be done on Study Weeks 3, 7, and 11.
干预措施: Microneedling (Procedure)
Microneedling Plus Universal Peel
(1) Microneedling treatment by the MicroPen with a Post-Microneedling Skin Care Regimen and the (2) Universal Peel by Topix with a Post-Universal Peel Skin Care Regimen will both be performed on a monthly basis for a total of three treatment sessions each.
Microneedling will be done on Study Weeks 1, 5, and 9. Universal Peel will be done on Study Weeks 3, 7, and 11.
干预措施: Post-Microneedling Skin Care (Drug)
Microneedling Plus Universal Peel
(1) Microneedling treatment by the MicroPen with a Post-Microneedling Skin Care Regimen and the (2) Universal Peel by Topix with a Post-Universal Peel Skin Care Regimen will both be performed on a monthly basis for a total of three treatment sessions each.
Microneedling will be done on Study Weeks 1, 5, and 9. Universal Peel will be done on Study Weeks 3, 7, and 11.
干预措施: Post-Universal Peel Skin Care (Drug)
结局指标
主要结局
Improvement in the appearance of acne scarring as measured by The Goodman and Baron Grading Scale.
时间窗: 6 months
The scale will be completed at every office visit over the 6 month study (Baseline, Weeks 1, 3, 5, 7, 9, 11, and 17).
Improvement in the appearance of acne scarring as measured by the 4 Point Scar Scale.
时间窗: 6 Months
The scale will be completed at each office visit during the 6 month study (Baseline, Weeks 1, 3, 5, 7, 9, 11, and 17).
Improvement in the appearance of acne scarring as measured by the Global Assessment.
时间窗: 6 months
The Global Assessment of Improvement will be completed at Week 17.
次要结局
- Improvement in the appearance of acne scarring as subjectively measured through digital pictures.(6 months)
- Patient-reported improvement in the appearance of acne scarring as measured by the Cardiff Index.(6 months)
- Patient reported improvement in appearance of acne scarring a measured by pre and post-treatment questionnaires.(6 months)