A clinical trial to compare the effectiveness and safety of a medicine called Tranexamic Acid when applied over the skin after creating tiny holes (microneedling) of different depths in reducing the darkness of dark spots of face (melasma)

Efficacy and Safety of Tranexamic Acid with Microneedling at Different Depths in Melasma: A Split Face Comparative Study - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/06/113046

Enrollment

Registered

2026-06-19

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: L811- Chloasma

Interventions

Intervention1: Microneedling with Tranexamic acid solution (greater than 1mm): Microneedling of one half of the face will be done using dermapen (with 16 needle cartridge) set for depth of greater tha

Eligibility

Inclusion criteria

Inclusion criteria: Clinically diagnosed cases of bilaterally symmetrical epidermal, dermal, or mixed melasma. Patients who are willing to give written informed consent.

Exclusion criteria

Exclusion criteria: Pregnant or lactating women. Patients with concurrent skin disease over face e.g. acne, herpes simplex virus infection, SLE, DLE, AD, naevus etc Patients with any other facial pigmentary dermatoses other than melasma. History of skin diseases having tendency of koebnerization like vitiligo, psoriasis and lichen planus. History of taking drugs causing pigmentation of skin like minocycline, hydroxychloroquines, clofazimine, OCPs, etc. History of abnormal wound healing, keloidal tendency or hypertrophic scarring. Patients with bleeding disorders or those on anticoagulant therapy. History of other treatments for melasma like topical depigmenting agents, chemical peels, or laser treatments within the past 4 weeks. Patients with known allergy to tranexamic acid or topical anesthetics. HIV, Hepatitis B or Hepatitis C positive individuals. Patients who are not willing to give written informed consent to participate.

Design outcomes

Primary

Measure	Time frame
Change in Hemi-modified Melasma Area and Severity Index (Hemi-mMASI) score Frequency of adverse events following procedure including post-inflammatory hyperpigmentation, prolonged erythema and swelling, and infection Timepoint: At 1 month, 2 months, 3 months, 4 months and 5 months	—

Secondary

Measure	Time frame
5 point Physician Assessment Score (PAS)Timepoint: At 1 month, 2 months, 3 months, 4 months and 5 months;4 point Patient Satisfaction Score (PSS)Timepoint: At 3 months, 4 months and 5 months;Severity of pain during procedure using Visual Analog Scale (0-10)Timepoint: On 1st day, At 1 month and 2 months;Severity of post procedure erythema (mild, moderate and severe)Timepoint: On 1st day, At 1 month and 2 months	—

Measure

Time frame

5 point Physician Assessment Score (PAS)Timepoint: At 1 month, 2 months, 3 months, 4 months and 5 months;4 point Patient Satisfaction Score (PSS)Timepoint: At 3 months, 4 months and 5 months;Severity of pain during procedure using Visual Analog Scale (0-10)Timepoint: On 1st day, At 1 month and 2 months;Severity of post procedure erythema (mild, moderate and severe)Timepoint: On 1st day, At 1 month and 2 months

—

Countries

India

Contacts

Public ContactAnand Agarwal

Kalpana Chawla Government Medical College

nidhikamra06@gmail.com9053366047

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 29, 2026