Efficacy of New Trio Combination for Melasma
Efficacy of New Trio Combination Versus Kligman's Formula In Treatment of Melasma
The goal of this clinical trial is to learn if the drug New Trio Combination (0.1% isobutylamido-thiazolyl-resorcinol, 0.1% retinoic acid and 0.1% dexamethasone) works to treat melasma. It will also learn about the safety of drug. This drug lowers the pigmentation severity by measuring modified Melasma Area and Severity Index (mMASI) reduction by up to 50%. The possible side effects of this drug are erythema and burning. We will compare this drug to kligman's formula (5% hydroquinon, 0.1% retinoic acid and 0.1% dexamethasone) to see if New Trio Combination works to treat melasma patients. All subjects will be divided in two groups. Group 1 will receive New trio combination (NT) and group 2 will receive Kligman's formula (KG), once daily (night time application) for 3 months. Patients will be called for follow up at 4, 8 and 12 weeks.
A total of 56 patients fulfilling the inclusion criteria are enrolled in the study. Efficacy of New Trio Combination versus Kligman's Formula will be measured in all selected patients suffering from melasma by estimating improvement in the modified MASI score and MELASQoL at each follow up.
研究概览
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
-
-
-
Lahore、巴基斯坦
- Ghurki Trust Teaching Hospital
-
-
参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
接受健康志愿者
描述
Inclusion Criteria:
- Female gender
- Age range: 16-60 years
Exclusion Criteria:
- Pregnant females
- Lactating mothers
- Those taking oral contraceptive pills and phenytoin
- Lost to follow up
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Intervention Group: Group A
Group A will receive New trio combination (NT) once daily
|
New trio combination is a drug containing 0.1% isobutylamido-thiazolyl-resorcinol, 0.1% retinoic acid and 0.1% dexamethasone
|
|
有源比较器：Control Group: Group B
Group B will receive Kligman's formula (KG), once daily
|
Kligman's formula (trio) is a drug containing 5% hydroquinone, 0.1% retinoic acid and 0.1% dexamethason
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Melasma Quality of Life (MELASQoL)
大体时间：Responses will be assessed at baseline, 4 weeks, 8 weeks, and 12 weeks
|
Melasma Quality of Life Scale (MELASQoL) will be used to assess the burden of melasma on patient's quality of life.
|
Responses will be assessed at baseline, 4 weeks, 8 weeks, and 12 weeks
|
|
modified Melasma Area and Severity Index (mMASI)
大体时间：Melasma severity over the course of 12 weeks of treatment, with responses assessed at baseline, 4 weeks, 8 weeks, and 12 weeks.
|
Melasma severity will be assessed by modified Melasma Area and Severity Index (mMASI).
|
Melasma severity over the course of 12 weeks of treatment, with responses assessed at baseline, 4 weeks, 8 weeks, and 12 weeks.
|
合作者和调查者
调查人员
- 研究主任：Prof. Dr. Haroon Nabi、Lahore Medical and Dental College
- 学习椅：Dr Aliza Hamadani、Lahore Medical and Dental College
- 学习椅：Dr. Ayesha Asad Chattha、Ghurki Trust Teaching Hospital
- 学习椅：Dr. Iram Kausar、Ghurki Trust Teaching Hospital
- 首席研究员：Dr. Meshaal Azhar、Ghurki Trust Teaching Hospital
出版物和有用的链接
一般刊物
- Kwon SH, Na JI, Choi JY, Park KC. Melasma: Updates and perspectives. Exp Dermatol. 2019 Jun;28(6):704-708. doi: 10.1111/exd.13844. Epub 2018 Dec 21.
- Banavase Channakeshavaiah R, Andanooru Chandrappa NK. Topical metformin in the treatment of melasma: A preliminary clinical trial. J Cosmet Dermatol. 2020 May;19(5):1161-1164. doi: 10.1111/jocd.13145. Epub 2019 Sep 10.
- Shokier DA, Mohamed HF, Badria FA. Is Topical Metformin Effective in Treatment of Melasma? The Egyptian Journal of Hospital Medicine. 2023 Jan 1;90(1):1407-12.
- Bertold C, Fontas E, Singh T, Gastaut N, Ruitort S, Wehrlen Pugliese S, Passeron T. Efficacy and safety of a novel triple combination cream compared to Kligman's trio for melasma: A 24-week double-blind prospective randomized controlled trial. J Eur Acad Dermatol Venereol. 2023 Dec;37(12):2601-2607. doi: 10.1111/jdv.19455. Epub 2023 Sep 4.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- R-22
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.