Oral tranexamic acid in the treatment of moderate to severe melasma.

Not yet recruiting

Conditions: Other disorders of skin and subcutaneous tissue in diseases classified elsewhere,

Registration Number: CTRI/2019/07/020340

Lead Sponsor: PGIMER Chandigarh

Brief Summary: Melasmais a common, acquired disorder of hyperpigmentation affecting millions ofpeople worldwide. It causes tremendous impact on the self esteem and quality oflife of the affected people, especially females. While various topical agentshave so far been the mainstay of treatment of melasma, they are plagued by sideeffects as well relapse and recurrences omce they are stopped. Oral tranexemicacid (TXA) is the latest tool in the armamentarium of melasma treatment. It hasso far been used in various forms including oral, topical and injectable withvariable but promising results. However, the dosingof TXA in melasma has been a cause of persistent speculation and this puzzle iswhat our study aims to shed some light on. Doses of TXA used for melasma instudies to date have ranged from 500 to 1,500mg daily.45 A typicaldose is 250 mg twice daily. Treatment is usually continued for 8 to 12 weeks.45This is in contrast to menorrhagia for which the dose is 3.9 to 4 g daily forup to 5 days per month.34 However, there is still no consensus toguide the dose and duration of therapy. There is also not much clarity on therisk of relapse after stopping oral TXA and if maintenance treatment isrequired and if so, if the duration of maintenance regimen differes withdifferent dosages of TXA. Studies have documented safe useof TXA formenorrhagia over the years with only minor side effects like nasal and sinusdiscomfort, back pain, musculoskeletal pain, oligomenorrhea, and abdominalcramps, with no evidence of ocular toxicity.22, 34, 35 Hence, at the dosages currently employed and based on available data, it seems unlikelythat TXA would increase risk of thrombotic complications, more so in theindications for which it is used in dermatology.

The present study is designed as a randomized, openlabel study in which 50 patients suffering from moderate to severe melasmaaccording to the mMASI scores will be recruited and be divided into two arms toreceive oral tranexemic acid at a dose of 250 mg twice a day or 500 mg twice aday for 12 weeks along with a sunscreen of SPF 30+. Theprimary objective is to evaluate and compare the efficacy of the two differentdosing regimens of TXA, that is, 250 mg twice daily versus 500 mg twice daily, usingthe mMASI score. The proportion ofpatients achieving mMASI 75 will be used as the proxy measure to assess theefficacy. The secondary aims will include assessing the MELASQOL score of thepatients at baseline and the end of treatment to have an objective analysis ofthe impairment of quality of life caused by melasma, apart from noting any adverseeffects, if any.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 50

Inclusion Criteria

Female and male patients aged more than 18 years with moderate to severe melasma (Moderate melasma will be defined as melasma patients with mMASI score of 5.8 to 7.9 and severe melasma as those with mMASI â‰¥ 8 based on defined ranges for melasma severity.46.

Exclusion Criteria

1.Known drug hypersensitivity to TXA.
2.Patients on medications for cardiovascular, gastrointestinal, hepatic, renal, disorders.
3.Pregnant or lactating mothers 4.Patients having history of hypercoagulable disorders or history of thrombotic episodes like deep vein thrombosis, pulmonary embolism, cerebral vein thrombosis.
5.Patients taking oral contraceptive pills.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.The primary objective is to evaluate and compare the efficacy of two different dosing regimens of TXA, that is, 250 mg twice daily versus 500 mg twice daily, using the mMASI score. The proportion of patients achieving mMASI 75 assesses the efficacy.	Baseline, monthly for 6 months.

Secondary Outcome Measures

Name	Time	Method
1.Proportion of patients achieving mMASI 90	2.To assess the dose of TXA that acts faster (time to achieve mMASI 75) and prevents relapse while on maintenance therapy.

Trial Locations

Locations (1): PGIMER Chandigarh
🇮🇳
Chandigarh, CHANDIGARH, India
PGIMER Chandigarh
🇮🇳Chandigarh, CHANDIGARH, India
M Sendhil Kumaran
Principal investigator
8872004023
drsen_2000@yahoo.com