A COMPARATIVE STUDY BETWEEN INTRALESIONAL TRANEXAMIC ACID AND MODIFIED KLIGMAN’S REGIMEN IN THE TREATMENT OF MELASMA PATIENTS FROM EASTERN INDIA
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Both groups of patients are assessed every 2 weeks with calculation of the MASI score up to 12 weeks
研究概览
简要总结
Melasma is a common acquired disorder characterised by symmetric hyperpigmented patches with an irregular outline occurring most commonly on the face Although the exact pathogenesis is unknown melasma is thought to be caused by hyperfunction of the melanocytes in the skin following UV exposure leading to increased amounts of melanin Additionally hyperestrogenic states oral contraceptive pills medications like phenytoin phototoxic drugsnthyroid disease have a role in the pathogenesis of melasma It commonly involves the centrofacial region forehead cheeks nose upper lip sparing the philtrum and nasolabial folds chin malar region less commonly the mandibular region Based upon its location of the pigment it can be classified into epidermal dermal mixed or indeterminate Theoretically on Woods Lamp examination epidermal type enhances whereas dermal melanin becomes less obvious but this does not correlate on histopathology On dermoscopy melasma appears as light to dark brown globules with perifollicular sparing and the pigmentation pattern is reticular or pseudoreticular with diffuse dark brown to grey pigmentation involving the follicular openings
As per Khuraiya et al melasma has been treated with various treatment modalities most importantly sunscreen triple combination creams azelaic acid ascorbic acid kojic acid and arbutus chemical peels lasers but none might prove fully effective
Tranexamic Acid is a plasmin inhibitor and an antifibrinolytic which has potential as an emerging treatment modality for Melasma It has some anti inflammatory and hypopigmentary properties when used either systemically or topically TA inhibits plasminogen activator which helps in plasminogen to plasmin conversion It inhibits melanin synthesis by interfering with melanocyte keratinocyte interaction by inhibiting the plasmin system
According to Sarkar et al The use of tranexamic acid in melasma was an accidental discovery by Nijo et al in 1979 in a patient with urticaria Further the identification of the vascular component in melasma pathogenesis led to its rapid and widespread usage
Although oral Tranexamic Acid has been proven to be an effective treatment strategy in many studies evidence is required in the field of usage of intralesional TA in the treatment of Melasma
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •patients attending the Dermatology OPD of IPGMER during the study period ages 18 to 60 years with bilaterally symmetrical or asymmetrical distribution of Melasma were included in the study with informed consent.
排除标准
- •Pregnant or lactating females or patients on hormone replacement therapy or oral contraceptive pills or bleeding disorders or concomitant use of anticoagulants and any known drug allergy and or hypersensitivity especially to TA or patients of topical steroid dependent facies or unwillingly patients or patients with high treatment expectations or associated medical illness or history of any other depigmenting treatment in the past 1 month were excluded from the study.
结局指标
主要结局
Both groups of patients are assessed every 2 weeks with calculation of the MASI score up to 12 weeks
时间窗: Both groups of patients are assessed every 2 weeks with calculation of the MASI score up to 12 weeks | Modified MASI Score by Amer A et al | It is calculated using | A Area of involvement | D Darkness | Modified Melasma Area Severity Index Scale | Along with forehead f right malar region rm left malar region lm and chin c corresponding to 30 percent 30 percent 30 percent and 10 percent of the total face, respectively. The total score range is 0 to 24 | 0.3AfD plus 0.3AlmDlm plus 0.3ArmDrm plus 0.1AcDc
Modified MASI Score by Amer A et al
时间窗: Both groups of patients are assessed every 2 weeks with calculation of the MASI score up to 12 weeks | Modified MASI Score by Amer A et al | It is calculated using | A Area of involvement | D Darkness | Modified Melasma Area Severity Index Scale | Along with forehead f right malar region rm left malar region lm and chin c corresponding to 30 percent 30 percent 30 percent and 10 percent of the total face, respectively. The total score range is 0 to 24 | 0.3AfD plus 0.3AlmDlm plus 0.3ArmDrm plus 0.1AcDc
It is calculated using
时间窗: Both groups of patients are assessed every 2 weeks with calculation of the MASI score up to 12 weeks | Modified MASI Score by Amer A et al | It is calculated using | A Area of involvement | D Darkness | Modified Melasma Area Severity Index Scale | Along with forehead f right malar region rm left malar region lm and chin c corresponding to 30 percent 30 percent 30 percent and 10 percent of the total face, respectively. The total score range is 0 to 24 | 0.3AfD plus 0.3AlmDlm plus 0.3ArmDrm plus 0.1AcDc
A Area of involvement
时间窗: Both groups of patients are assessed every 2 weeks with calculation of the MASI score up to 12 weeks | Modified MASI Score by Amer A et al | It is calculated using | A Area of involvement | D Darkness | Modified Melasma Area Severity Index Scale | Along with forehead f right malar region rm left malar region lm and chin c corresponding to 30 percent 30 percent 30 percent and 10 percent of the total face, respectively. The total score range is 0 to 24 | 0.3AfD plus 0.3AlmDlm plus 0.3ArmDrm plus 0.1AcDc
D Darkness
时间窗: Both groups of patients are assessed every 2 weeks with calculation of the MASI score up to 12 weeks | Modified MASI Score by Amer A et al | It is calculated using | A Area of involvement | D Darkness | Modified Melasma Area Severity Index Scale | Along with forehead f right malar region rm left malar region lm and chin c corresponding to 30 percent 30 percent 30 percent and 10 percent of the total face, respectively. The total score range is 0 to 24 | 0.3AfD plus 0.3AlmDlm plus 0.3ArmDrm plus 0.1AcDc
Modified Melasma Area Severity Index Scale
时间窗: Both groups of patients are assessed every 2 weeks with calculation of the MASI score up to 12 weeks | Modified MASI Score by Amer A et al | It is calculated using | A Area of involvement | D Darkness | Modified Melasma Area Severity Index Scale | Along with forehead f right malar region rm left malar region lm and chin c corresponding to 30 percent 30 percent 30 percent and 10 percent of the total face, respectively. The total score range is 0 to 24 | 0.3AfD plus 0.3AlmDlm plus 0.3ArmDrm plus 0.1AcDc
Along with forehead f right malar region rm left malar region lm and chin c corresponding to 30 percent 30 percent 30 percent and 10 percent of the total face, respectively. The total score range is 0 to 24
时间窗: Both groups of patients are assessed every 2 weeks with calculation of the MASI score up to 12 weeks | Modified MASI Score by Amer A et al | It is calculated using | A Area of involvement | D Darkness | Modified Melasma Area Severity Index Scale | Along with forehead f right malar region rm left malar region lm and chin c corresponding to 30 percent 30 percent 30 percent and 10 percent of the total face, respectively. The total score range is 0 to 24 | 0.3AfD plus 0.3AlmDlm plus 0.3ArmDrm plus 0.1AcDc
0.3AfD plus 0.3AlmDlm plus 0.3ArmDrm plus 0.1AcDc
时间窗: Both groups of patients are assessed every 2 weeks with calculation of the MASI score up to 12 weeks | Modified MASI Score by Amer A et al | It is calculated using | A Area of involvement | D Darkness | Modified Melasma Area Severity Index Scale | Along with forehead f right malar region rm left malar region lm and chin c corresponding to 30 percent 30 percent 30 percent and 10 percent of the total face, respectively. The total score range is 0 to 24 | 0.3AfD plus 0.3AlmDlm plus 0.3ArmDrm plus 0.1AcDc
次要结局
- PGA Score and PtGA Score every 4 weeks and photographs taken fortnightly up to 12 weeks(PHYSICIANS GLOBAL ASSESMENT SCALE PGA)
研究者
Meenakshi Khemka
Institute of Post Graduate Medical Education and Research and SSKM Hospital Kolkata