A comparative study of microneedling versus intradermal injection using tranexamic acid in the treatment of Melasma

Completed

Conditions: Other melanin hyperpigmentation,

Registration Number: CTRI/2023/05/052649

Lead Sponsor: AARUPADAI VEEDU MEDICAL COLLEGE,PONDICHERRY

Brief Summary: Melasma is a complicated disorder whose management is very resistant to treatment and also affects the quality of life adversely.Incidence among Indians are 10%.1st line treatment includes topical medications followed by chemical peels and lasers.Despite numerous therapies treatment remains difficult.So there is a need for study of novel agents like Tranexamic acid in the treatment of Melasma.So this study attempts to compare the efficacy of Tranexamic acid micro needling and Intradermal injection in the treatment of Melasma among the Outpatients of the department of dermatology.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 70

Inclusion Criteria

1.Patients with Epidermal/Dermal /Mixed type of melasma 2.Patients willing for consent, study and follow up.

Exclusion Criteria

1.Pregnancy 2,Patients on hormone replacement therapy 3.Patients on contraceptive pills 4.Patients on anticoagulants 5.Allergic to drugs under the study 6.Non compliant patients 7.Patients with keloidal or Hypertrophic scar tendency 8.Patients with the history of depigmenting treatment in the past 1 month 9.Moderate to severe acne vulgaris on face 10.History of Herpes infections, Warts.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Modified Melasma Area and Severity Index (Modified MASI) score: Primary outcome to assess treatment response.	At baseline,4weeks, 8weeks & 12 weeks and followed up for further 2 months at monthly intervals.

Secondary Outcome Measures

Name	Time	Method
Patient global assessment scale and	At baseline, 4weeks, 8weeks & 12 weeks and followed up for further 2 months at monthly intervals.
Clinical improvement assessed based on photographic document	At baseline, 4weeks, 8weeks & 12 weeks and followed up for further 2 months at monthly intervals.

Trial Locations

Locations (1): Aarupadai Veedu medical college,
🇮🇳
Pondicherry, PONDICHERRY, India
Aarupadai Veedu medical college,
🇮🇳Pondicherry, PONDICHERRY, India
SRIJHA M
Principal investigator
9965929696
srijhafeb@gmail.com