New Treatment in Melasma

NCT07887399 | Not Yet Recruiting

• 1 other identifier: Soh-Med-26-9-19MS
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial aims to compare different therapeutic approaches for the treatment of melasma. Participants will be randomly allocated into three treatment groups receiving modified Kligman formula, microneedling-assisted topical tranexamic acid, or nanotechnology-based topical tranexamic acid. The study will compare these treatment approaches over a defined treatment period followed by a follow-up period. The study will provide evidence regarding the comparative efficacy and safety of these therapeutic modalities in patients with melasma.

Conditions

Female; With; Facial; Melasma

Keywords

Melasma; Tranexamic acid; Microneedling; Nano-based Technology

Outcome Measures

Primary Outcomes (1)

• Change in Melasma Area and Severity Index (MASI) score from baseline to the end of the treatment period

  The mean change in MASI score from baseline to the end of the treatment period (4 months) will be compared among the three treatment groups.

  4 months after initiation of treatment

Secondary Outcomes (3)

• Percentage change in Melasma Area and Severity Index (MASI) from baseline to the end of treatment

  4 months after initiation of treatment

• Patient Satisfaction assessed using a 4-point patient satisfaction scale

  4 months after initiation of treatment

• Incidence of treatment-related adverse events

  from initiation of treatment to the end of the treatment period(4months)

Study Arms (3)

Group A: Nanotechnology-based Topical Tranexamic Acid

ACTIVE COMPARATOR

Group A: will use daily topical TXA 3% +ZnO suspension (Nano-based Technology) on the entire face 2 times per day

Drug: Tranexamic Acid - topical

Group B: Microneedling + Topical Tranexamic acid

ACTIVE COMPARATOR

Group B: will undergo microneedling over the face for a maximum 4 sessions with a 4-week interval between each session followed by topical TXA gel 3% after session and on daily basis over entire face 2 times per day. Microneedling will be done using (Derma Pen Maglev 3,Germany) with a 32-needle head with a needle depth ranging from 0.25 to 1 mm and adjusted according to the thickness and anatomical site of facial skin

Procedure: Microneedling with Topical Tranexamic acid

Group C: Modified Kligman Formula

ACTIVE COMPARATOR

Group C: will use modified Kligman formula every night

Drug: Modified Kligman's Formula

Interventions

Modified Kligman's Formula DRUG

Group C: will use modified Kligman formula every night.

Group C: Modified Kligman Formula

Tranexamic Acid - topical DRUG

Group A: will use daily topical TXA 3% +ZnO suspension (Nano-based Technology) on the entire face 2 times per day. Nanotechnology based formulations are able to overcome skin barrier so the drug will be retained in the epidermis to target melanocytes

Also known as: Nanotechnology-based Tranexamic Acid

Group A: Nanotechnology-based Topical Tranexamic Acid

Microneedling with Topical Tranexamic acid PROCEDURE

Group B: will undergo microneedling over the face for a maximum 4 sessions with a 4-week interval between each session followed by topical TXA gel 3% after session and on daily basis over entire face 2 times per day. Microneedling will be done using (Derma Pen Maglev 3,Germany) with a 32-needle head with a needle depth ranging from 0.25 to 1 mm and adjusted according to the thickness and anatomical site of facial skin

Also known as: Microneedling-assisted topical TXA

Group B: Microneedling + Topical Tranexamic acid

Eligibility Criteria

• Age: 18 Years - 60 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adult females≥18 years
• All types of Melasma of any severity (epidermal, dermal and mixed)
• Fitzpatrick skin types II-V

You may not qualify if:

• \- Recent treatment of Melasma (3months before enrollement in the study)
• Pregnancy and lactation
• Scarring or Keloidal tendency
• Active infection
• Medical treatment including: hormonal therapy, anticoagulant, antiplatelet and photosensitizing drugs
• Systemic diseases including: DM, HTN, Malignancy and bleeding disorders
• Other causes of hyperpigmentation

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Faculty of Medicine Sohag University

Sohag, Egypt

Location

MeSH Terms

Conditions

Facies; Melanosis

Interventions

Tranexamic Acid; Percutaneous Collagen Induction

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Punctures; Rehabilitation

Central Study Contacts

Amira Gamal Thabet, Resident doctor

CONTACT

201124712921; mirothabet9@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician

Study Record Dates

• First Submitted: October 7, 2026
• First Posted: October 21, 2026
• Study Start: October 18, 2026
• Primary Completion (Estimated): February 18, 2027
• Study Completion (Estimated): June 18, 2027
• Last Updated: October 21, 2026

Record last verified: 2026-10

Locations

EG (1)