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

To evaluate the efficacy of Q-switched ND:YAG laser plus tranexamic acid (injection/topical) for melasma, compared to standard treatment with modified Kligman's formula.

Randomized, three-arm, double-blind clinical trial with permuted block randomization؛ assessor and analyst blinded؛ minimum 15 patients per group؛ intention-to-treat analysis.

Conducted at dermatology clinic of Hazrat Fatemeh Hospital؛ patients enrolled after informed consent and randomized؛ outcomes (mMASI, VAS) assessed at baseline، 8 weeks and 1 month post-treatment؛ sunscreen use permitted during follow-up.

Aged 18 to 60 years؛ diagnosed with melasma on cheeks or forehead؛ patients referred to dermatology clinic of Rasul Akram Hospital؛ willing to provide informed consent؛ able to attend follow-up visits؛ no melasma treatment in past one month.Major exclusion criteria prior to randomization History of other inflammatory skin diseases in melasma areas, photosensitivity disorders, pregnancy or lactation, allergy to Kligman's formula, recent melasma treatments (past 3 months), uncontrolled systemic diseases, recent hormonal therapy, non-compliance risk, interfering scars/tattoos, Fitzpatrick skin type VI

Control group: Q-switched ND:YAG 1064nm laser (2 sessions with 4-week intervals) plus modified Kligman’s formula every other night for 8 weeks. Injection group: same laser and cream as control plus intradermal 10% tranexamic acid injections (dose adjusted by lesion extent) at baseline, week 4, and week 8. Topical group: same laser and cream as control plus topical 5% tranexamic acid applied every other night alternating with Kligman’s formula for 8 weeks.

Melasma severity measured by mMASI score؛ symptom severity (pain, irritation) measured by Visual Analogue Scale؛ patient satisfaction and adverse events.

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.

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.

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.

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

Academic researchers and qualified research institutions with a formal request and a clear scientific objective.

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.

Requests should be submitted to the principal investigator:

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.

All data will be encrypted and shared in Excel or CSV format. Data sharing will comply with ethical research standards and participant confidentiality protection.