Comparative efficacy of Q switched NdYAG laser with 0.1 percent Tacrolimus ointment versus 0.1 percent Tacrolimus ointment alone in the treatment of Acquired Dermal Macular Hyperpigmentation A Randomized Controlled Trial

This protocol outlines a randomized controlled trial to compare the effectiveness of two treatments for Acquired Dermal Macular Hyperpigmentation (ADMH). The study aims to determine if a combination therapy of Q-switched Nd-YAG laser with 0.1% tacrolimus ointment is more effective than using 0.1% tacrolimus ointment alone. The primary objective is to compare changes in the Dermal Pigmentation Area and Severity Score (DPASI) and Physician’s Global Assessment. Secondary objectives include assessing patient satisfaction, quality of life using the Dermatology Life Quality Index (DLQI), and monitoring adverse effects.

The study is an open-label, randomized controlled trial involving 42 adult participants with a confirmed diagnosis of stable ADMH. The participants will be randomly allocated into two groups. Group A will receive four sessions of Q-switched Nd-YAG laser at four-week intervals, in addition to applying 0.1% tacrolimus ointment twice daily. Group B will apply 0.1% tacrolimus ointment twice daily for 16 weeks. Both groups will also use broad-spectrum sunscreen.

Evaluations will be conducted at baseline, week eight, and week 18. Baseline assessments include detailed history, examination, photographs, and calculation of the DPASI and DLQI scores. Following the treatment, improvement will be assessed using DPASI scores, clinical photographs, and patient satisfaction scores. Data will be recorded and statistically analyzed using chi-square tests, with a p-value less than 0.05 considered significant. Ethical clearance will be obtained, and all participants will provide informed, written consent.