A clinical trial to study the effects of two drugs, Tranexamic acid and Hydroquinone in patients with melasma

Completed

• Conditions: Melasma

• Registration Number: CTRI/2017/10/010049
• Lead Sponsor: Dr Manasa S J

Brief Summary

Melasma is a common,frequently relapsing acquired hypermelanosis of sunexposed areas. It is commonin darker skin types and has a female preponderance. The exact etiopathogenesisof melasma remains elusive and various factors like genetic predisposition, sun-exposure,hormones, vascular factors influence its development. Presently, there is no universally effectiveprocedure or agent for melasma treatment despite the availability of varioustherapeutic modalities. However, hydroquinone has shown some benefits in melasma sincelast five decades. Melasma responds relatively slow to treatment and tends torecur. In view of the adverse effects associated with hydroquinone, its longterm use is not recommended. A multitude of alternatives ranging from natural extracts to LASERs havebeen extensively investigated for melasma. Preliminary trials with tranexamicacid are encouraging and its efficacy at various strengths, formulations andtypes of melasma are being explored.

Our study aimed atassessing the efficacyof topical 5% tranexamic acid solution versus 3% hydroquinone cream in melasma.After obtaining informed consent and randomization into two interventiongroups, 100 eligible patients of melasma were provided with theabove mentioned preparations for once dailyapplication for 12 weeks. MASI and photographs at baseline, weeks 4, 8 and 12were documented. Subjective improvement was assessed at the end of the study bypatient satisfaction score.

Our study populationconsisted of 84 females and 16 males with 35.86+ 7.40years in males and 36.18+ 7.52 years infemales. Majority of the patients developed melasma in the fourth decade oftheir lives and only 12% had an onset during pregnancy and in 12% it wasassociated with hypothyroidism. About 50% of the patients in thisstudy belonged to Fitzpatrick skin type IV, followed by type V(46%). Mixedmelasma had the highest prevalence(63%) followed by epidermal type in 22% anddermal type in 15% of the study population.

The mean MASI scoresin TA and HQ groups at baseline were 12.39±3.34and 11.63 ± 3.72 respectively and after 12 weeks of study were 9.47±2.79 and9.24±3.26 respectively. Percentage reduction of MASI in TA group was 27%and in HQ group was 26.7% and the difference in the reduction between the two groups wasnot significant (*P*> 0.05). Patient satisfaction score, a tool forsubjective assessment of improvement showed significantly better results in TAgroup(P value-0.03).

TAappears to be a promising agent in thetreatment of melasma. However, large scale studies are needed to establish itsefficacy and safety in skin of color.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-01
• Last Update Posted: 2017-06-10
• Study Completion: 2017-06-30

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1.Previously treated cases of melasma,not applying topical medication for past 1 month.

Exclusion Criteria

• Pregnant and nursing women.
• 2.Women on OCPs 3.Patients on photosensitizing drug.4.Patients with clotting disorders 5.
• Patients on concurrent treatment for melasma.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction in mean MASI score	0,4,8,12th week

Secondary Outcome Measures

Name	Time	Method
No improvement in MASI score	12 weeks

Trial Locations

Locations (1)

Command Hospital Airforce Bangalore; 🇮🇳 Bangalore, KARNATAKA, India

Command Hospital Airforce Bangalore

🇮🇳Bangalore, KARNATAKA, India

Manasa S J

Principal investigator

9844855195

manasajanne@gmail.com