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IRCT20250522065847N1 IRCT 2025-08-08 Iran University of Medical Sciences This trial compares intradermal 10% vs. topical 5% tranexamic acid for melasma treatment alongside modified Kligman’s formula and Q-switched Nd:YAG laser. 1- Comparison of Efficacy, safty, satisfaction and treatment duribility of intradermal injection of 10% tranexamic acid versus 5% topical tranexamic acid cream in patients under treatment with topical Modified Kligman's formula plus fractional Q-switch 1064 Nd:YAG laser,Triple arm ,paralell groups,Assessor analysis blinded, Randomized controlled ,Clinical Traial 2025-04-21 anticipated 45 Complete https://irct.ir/trial/83747 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Here's the English translation of your text in a clear and academic tone: Randomization and Allocation Method: In the present study, participants will be allocated to groups using permuted block randomization. First, a randomization sequence will be generated by the researchers, followed by participant recruitment. Blocks of three will be formed, and blocks will be selected randomly until the required sample size is achieved. To maintain allocation concealment, the interventions will be coded as A, B, and C, without revealing the actual treatment names. This process ensures randomization concealment. Allocation to groups, patient enrollment, and treatment side designation will be performed by the first assessor according to the described protocol. In cases of protocol deviations, including issues related to treatment allocation, randomization, or follow-up completion, intention-to-treat (ITT) analysis will be employed. Only participants with at least 80% compliance will be included in the analysis. Those with lower compliance will be excluded from the study, Blinding description: The present study will be conducted in a double-blind manner, meaning that both the assessor and the data analyst will be blinded to the group allocation and the type of treatment administered to each participant. N/A Melasema. Intervention 1: Control group: :Participants in the control group receive fractional Q-switched 1064-nm ND:YAG laser therapy with melasma-specific settings (average energy 600 nm, 5 Hz, spot size = 5 mm, 1500 shots for full face or 300–400 shots per cheek). Two sessions are performed four weeks apart. Additionally, they apply a topical Modified Kligman’s formula consisting of hydroquinone 4 g, vitamin C 3 g, and retinol 3 cc in cold cream base up to 100 g, every other night for 8 weeks. Intervention 2: Intervention group: Intervention group 1: Participants receive intradermal injections of 10% tranexamic acid based on the severity of melasma: mild (0.5 cc), moderate (1 cc), severe (1.5–2 cc per cheek), up to 4 cc for the full face. Injections are administered in three sessions, each four weeks apart: at baseline (after first laser session), four weeks after the second laser session, and four weeks after completion of the second laser session. Intervention 3: Intervention group: Intervention group 2: Participants apply topical 5% tranexamic acid (Dermalift) and Modified Kligman’s formula every other night on the affected areas. The Modified Kligman’s formula contains hydroquinone 4 g, vitamin C 3 g, and retinol 3 cc in cold cream base up to 100 g. Treatment continues for 8 weeks. Yes - There is a plan to make this available What will be shared: De-identified individual participant data including age, gender, baseline and final MASI scores, type of intervention, and clinical outcomes. Only anonymized data with no identifying information will be shared. When: Data will be available six months after study completion and publication of the main results. The access period begins six months after the publication date To whom: Academic researchers and qualified research institutions with a formal request and a clear scientific objective. Conditions: Data may only be used for research purposes such as meta-analyses, secondary data analysis, or validation of results. Requesters must sign a Data Use Agreement (DUA) prior to access. Where to obtain: Requests should be submitted to the principal investigator: How to obtain: The request must be submitted formally via email to the principal investigator. Upon review and approval of the research purpose, a Data Use Agreement (DUA) will be sent. Once signed, data will be provided within 2–4 working weeks. Comments: All data will be encrypted and shared in Excel or CSV format. Data sharing will comply with ethical research standards and participant confidentiality protection.
public Hamid Rahimi
Asadabadi St., Alley 21, Hazrat Fatemeh Hospital, Yousef Abad, Tehran
Tehran Iran (Islamic Republic of) 1444763735 +98 21 4447 4661 Rahimihamid1372@gmail.com Iran University of Medical Sciences scientific Dr. Azadeh Goodarzi
: Asadabadi St., Alley 21, Hazrat Fatemeh Hospital, Yousef Abad, Tehran
Tehran Iran (Islamic Republic of) 1433933111 +98 21 8870 0528 azadeh.goodarzi@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) The study includes individuals with melasma presenting unilaterally, bilaterally, or on the forehead. 18 years 60 years Both 1. Presence of other inflammatory dermatoses in the affected areas (e.g., rosacea, lupus, atopic dermatitis)2. History of photosensitive disorders or use of photosensitizing medications3. Pregnancy or lactation at the time of study entry4. History of hypersensitivity or allergy to Kligman's formula or any of its components5. Undergoing effective treatments for melasma (e.g., laser therapy, chemical peeling, microneedling) within the past 3 months6. Uncontrolled systemic diseases (e.g., uncontrolled diabetes, active hepatic or renal disease)7. Use of hormonal medications (e.g., oral contraceptives or hormone therapy) within the past 3 months8. Lack of willingness to adhere to treatment protocols or attend follow-up visits9. Presence of prominent scars or tattoos in the melasma-affected areas that may interfere with evaluation L81.1 Chloasma Treatment - Drugs Treatment - Drugs Treatment - Drugs Control group: :Participants in the control group receive fractional Q-switched 1064-nm ND:YAG laser therapy with melasma-specific settings (average energy 600 nm, 5 Hz, spot size = 5 mm, 1500 shots for full face or 300–400 shots per cheek). Two sessions are performed four weeks apart. Additionally, they apply a topical Modified Kligman’s formula consisting of hydroquinone 4 g, vitamin C 3 g, and retinol 3 cc in cold cream base up to 100 g, every other night for 8 weeks. Intervention group: Intervention group 1: Participants receive intradermal injections of 10% tranexamic acid based on the severity of melasma: mild (0.5 cc), moderate (1 cc), severe (1.5–2 cc per cheek), up to 4 cc for the full face. Injections are administered in three sessions, each four weeks apart: at baseline (after first laser session), four weeks after the second laser session, and four weeks after completion of the second laser session. Intervention group: Intervention group 2: Participants apply topical 5% tranexamic acid (Dermalift) and Modified Kligman’s formula every other night on the affected areas. The Modified Kligman’s formula contains hydroquinone 4 g, vitamin C 3 g, and retinol 3 cc in cold cream base up to 100 g. Treatment continues for 8 weeks. Melasma severity is evaluated based on the Melasma Area and Severity Index (MASI) score in the forehead, right malar, and left malar regions. The MASI score incorporates assessment of involved area, pigmentation intensity, and homogeneity of the lesion. Timepoint: MASI is measured at baseline (before the start of treatment), one month after the start of treatment, and two months after the start of treatment. Method of measurement: Clinical examination and recording of MASI score by a dermatologist using the standard calculation formula. Overall patient satisfaction with the treatment outcome is assessed two months after the start of treatment using a 5-point ordinal scale (excellent, good, moderate, poor, no satisfaction). Timepoint: At the end of the second month of treatment. Method of measurement: Patient interview and recording of response using an ordinal scale form. The intensity of itching in the treated area. Timepoint: Immediately after treatment, one week after treatment, and one month after treatment. Method of measurement: Patient-reported numerical rating scale from zero (no itching) to ten (worst imaginable itching). The intensity of burning sensation in the treated area. Timepoint: Immediately after treatment, one week after treatment, and one month after treatment. Method of measurement: Patient-reported numerical rating scale from zero (no burning) to ten (worst imaginable burning). Patient satisfaction level regarding treatment outcome. Timepoint: One month and two months after the beginning of treatment. Method of measurement: Patient-reported five-point Likert scale satisfaction questionnaire (from completely dissatisfied to completely satisfied). Iran University of Medical Sciences Approved 2025-03-21 "Ethics Committee of Iran University of Medical Sciences" Iran University of Medical Sciences Shahid Hemmat Highway (beside Milad Tower), Kooy Nasr (Kuy-e Nasr), Tehran, Iran Tehran Tehran Iran (Islamic Republic of)