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临床试验/NCT05909072
NCT05909072尚未招募2 期

The Boosting Effect of Hyaluronic Acid on Tranexamic Acid Microneedles in Melasma Patients: A Split- Face Study

Zagazig University0 个研究点目标入组 27 人开始时间: 2023年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
尚未招募
入组人数
27
主要终点
A five-point Likert scale for patient's satisfaction

研究概览

简要总结

Topical tranexamic, a hydrophilic molecule, can't pass the lipid barriers of the stratum corneum and it's also not retained in adequate amount in the epidermis to enter the melanocytes, so there's a difficulty in the effective delivery of tranexamic acid into the melanocytes .

Hyaluronic acid was proved to improve the effective delivery of tranexamic acid through loosening corneocyte packing and helping TXA entering the melanocytes and minimizing its epidermal diffusion .

详细描述

Melasma is a common acquired pigmentary disorder characterized by irregular symmetric medium- to dark-brown macules and patches affecting the photoexposed areas of the face causing cosmetic disfigurement and low quality of life of the patient. Melsama affects mostly women of reproductive age with Fitzpatrick skin type IV-VI .

The exact pathogenesis of melasma isn't well-known, however the major etiological factors include genetic influences, chronic sun exposure, pregnancy, contraceptives, drugs and hormone therapy. Although the exact pathogenesis of melasma is not fully clarified, the pathophysiology of melasma is believed to involve excess production of melanin or an increase in the activity of melanocytes in the skin .

Melasma is often refractory to treatment with common relapses, so it needs a treatment modality that can be used for long time with minimal side effects. Topical depigmenting agents have good results but also may lead to many side effects.

Microneedling is a minimally invasive technique used for skin rejuvenation and treatment of many diseases, such as dyspigmentation. Gentle microneedling enhances upper dermal changes and increases the epidermal turnover that leads to decreasing melanin production and its deposition in melanocytes and also increasing the epidermal melanin cleareance which improve melasma.

Microneedling enhances transdermal drug delivery across the skin barrier through creating microchannels into the skin without causing actual epidermal damage. Microneedling with topical tranexamic acid (TXA) was proved to be safe, effective and comparatively painless without any detectable side effects.

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 (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged > 18 years.
  • Both sexes.
  • All types of melasma (epidermal, dermal and mixed).
  • Nearly bilateral symmetrical melasma

排除标准

  • Pregnancy and lactation
  • Patients who are taking contraceptive pills at the time of the study or during the past 12 months.
  • Patients with bleeding disorders with hypercoagulable state or the concomitant use of anticoagulants.
  • Patient with history of thrombosis like DVT, coronary artery disease, stroke.
  • Patient using any treatment for melasma during the past 1 month before the study.
  • Active skin infection.
  • Infection and immunosuppression
  • Patient with keloidal tendency

研究组 & 干预措施

right side of the face

Active Comparator

microneedling with tranexamic acid alone on the right side of the face

干预措施: tranexamic acid microneedling (Drug)

Left side of the face

Active Comparator

microneedling with tranexamic acid combined with hyaluronic acid on the left side

干预措施: Hyaluronic acid combined with tranexamic acid microneedling (Drug)

结局指标

主要结局

A five-point Likert scale for patient's satisfaction

时间窗: through study completion, an average of 9 months

Level of patient satisfaction is scored on five points: 1. Not at all satisfied 2. Not really satisfied 3. Undecided 4. Somewhat satisfied 5. Very much satisfied

Dermoscopic evaluation

时间窗: through study completion, an average of 9 months

Dermoscopy will be performed for each patient at baseline, during and after each follow-up visit to evaluate the improvement of: * Color (light brown, brown, dark brown) * Pigmentation (pseudo network and arcuate lesions) * Vascularity (present or absent telangiectasia)

Modified Melasma Area Severity Index (mMASI) score

时间窗: through study completion, an average of 9 months

Hemi-mMASI for each half of the face is calculated according to the following formula: Hemi-mMASI = 0.15 (A) (D) F + 0.3 (A) (D) M + 0.05 (A) (D) C

Physician global evaluation

时间窗: through study completion, an average of 9 months

The improvement of patients is evaluated regarding the improvement in mMASI ( ) and graded as follow: Poor (improvement \< 25%) Fair (improvement 26%-50%) Good (improvement 51%-75%) Excellent (improvement \>75%)

Pain assessment

时间窗: through study completion, an average of 9 months

Pain during the session will be assessed and graded as mild, moderate and severe

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Norhan Anees

principal investigator

Zagazig University

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