Clinical Utility of Sepia Officinalis in Female Patients with Melasma Interpreted by Modified Melasma Area and Severity Index (MMASI): A Pilot Clinical Prospective Study

Authors: Devanshi Doshi, Rajesh Sanjha, Dr. Vani Oza

Country: India

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Abstract: Melasma is a common acquired disorder of facial hyperpigmentation characterized by symmetrical brown-to-greyish macules and patches, predominantly affecting females. It commonly involves the forehead, malar regions and chin and may have a chronic, relapsing course. Assessment of treatment response requires a reproducible clinical severity measure. The modified Melasma Area and Severity Index (mMASI) is a simplified and validated clinical scoring system that assesses the area and darkness of pigmentation over four facial regions.
Aim
To explore the clinical utility of the homoeopathic medicine Sepia officinalis in female patients suffering from melasma, using the mMASI score as an objective clinical outcome measure.
Objectives
1.To assess the severity of melasma in female patients using the mMASI score.
2.To evaluate changes in mMASI scores following individualized homoeopathic treatment with Sepia officinalis.
3.To assess the percentage improvement in mMASI score during the observation period.
4.To determine the feasibility of using mMASI as an outcome measure in a larger prospective study.
5.To generate preliminary data for planning the sample size and methodology of the definitive study.
Methods
A hypothetical pilot cohort of 12 female patients with clinically diagnosed melasma was constructed for methodological demonstration. Patients were assumed to receive individualized treatment with Sepia officinalis according to the study protocol and were followed for 12 weeks. mMASI scores were recorded at baseline and at 4, 8 and 12 weeks. Descriptive statistics were calculated, together with paired statistical comparisons between baseline and follow-up values.
Results
The simulated baseline mean mMASI score was 6.00 ± 1.31. The mean score decreased to 5.51 ± 1.20 at 4 weeks, 4.91 ± 1.07 at 8 weeks and 4.31 ± 0.95 at 12 weeks. The mean reduction at 12 weeks was 1.69 points, corresponding to approximately 28.2% reduction from baseline. A paired t-test demonstrated a statistically significant reduction between baseline and week 12 (t = 15.52, df = 11, p < 0.001). The 95% confidence interval for the mean reduction was approximately 1.45–1.93 points.
Conclusion
This simulated pilot dataset demonstrates how a prospective study of Sepia officinalis in female patients with melasma could be analysed using mMASI. The observed pattern suggests progressive reduction in mMASI scores over 12 weeks. However, because these are simulated data, the findings cannot be interpreted as evidence of treatment efficacy. Actual clinical observations are required before drawing conclusions regarding the clinical utility of Sepia officinalis.

Keywords: Melasma; Sepia officinalis; Homoeopathy; Modified Melasma Area and Severity Index (mMASI); Facial hyperpigmentation; Female patients; Pigmentation disorder; Clinical prospective study; Pilot study.

Paper Id: 233219

Published On: 2026-09-19

Published In: Volume 14, Issue 5, September-October 2026

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