跳至主要内容
临床试验/TCTR20200710001
TCTR20200710001招募中1 期

Efficacy and safety of 0.15% Thiamidol combination with hyaluronic acid versus 0.15%Thiamidol or hyaluronic acid alone in treatment of melasma : A randomized single-blind trial

Faculty of medicine, Thammasat university0 个研究点目标入组 96 人开始时间: 2020年7月10日最近更新:
适应症

试验速览

阶段
1 期
状态
招募中
发起方
入组人数
96

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 Years 至 65 Years(—)
性别
Female

入选标准

  • 1.Women 18-65 years of age having general good health
  • 2.Fitzpatrick skin type II-IV
  • 3.Individuals with any types of melasma
  • 4.Individuals who use sunscreen daily with at least SPF30
  • 5.Individuals that willing to provide written informed consent and are able to read, speak, write, and understand Thai.
  • 6.Individuals of child-bearing potential who are willing to take a urine pregnancy test prior to study enrollment and when deemed appropriate by the investigator and/or sponsor
  • 7. Individuals of child-bearing potential who use an acceptable method of contraception throughout the study and must be on a stable use for 3 months prior to study enrollment and must not alter their use, including dose or regimen for the duration of the study
  • 8. Willing to withhold all facial treatments during the course of the study, including botulinum toxin, injectable fillers, microdermabrasions, intense pulse light, peels, laser treatment and thread
  • 9. Willing to co-operate and participate by following study requirements for the duration of the study and to report any changes in health status or medications, adverse event symptoms, or reactions immediately

排除标准

  • 1. History of laser resurfacing procedures, deep skin peel,
  • botulinum toxin, or injection with a dermal filler, or
  • cosmetic procedures on the face within 6 months prior to
  • enrollment.
  • 2. Use of depigmenting products within 2 months prior to
  • enrollment.
  • 3. Use of any topical medications on the face for the
  • treatment of hyperpigmented lesions or other conditions,
  • or use of photosensitizing medication or procedures,
  • bleaching products on the face, UV light therapy, topical
  • prescription treatments, transamin, glutathione, vitamin or topical tretinoin on the face, or Use of acitretin, isotretinoin, systemic retinoids, methotrexate, or photoallergic, phototoxic, or photo-sensitizing drugs fewer than 30 days prior to the study entry.
  • 4. Facial microdermabrasion treatment within 6 weeks
  • prior to study entry.
  • 5. Known allergies to facial skin care products.
  • 6. Pregnancy or nursing or planning to become pregnant
  • during the study according to subject self-report,
  • including those who are not using an acceptable
  • method of contraception throughout the study.
  • 7. History of skin cancer.
  • 8. A health condition and/or pre-existing or dormant
  • dermatologic disease on the face (e.g., psoriasis, rosacea,
  • acne, eczema, seborrheic dermatitis, severe excoriations)
  • that the investigator deems inappropriate for participation
  • or could interfere with the outcome of the study.
  • 9. History of immunosuppression/immune deficiency disorders, including HIV infection or acquired immunedeficiency syndrome, or currently using immunosup-
  • pressive medications and/or radiation as determined by study
  • documentation.
  • 10. Uncontrolled disease such as asthma, diabetes, hyper-
  • tension, hyperthyroidism, or hypothyroidism. Individuals
  • having multiple health conditions may be excluded from
  • participation even if the conditions are controlled by diet
  • or medication.

研究者

发起方
Faculty of medicine, Thammasat university

相似试验