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Introduction <p>Topical treatment with hydroquinone 4% and hydroquinone-based preparations is the gold standard of care for melasma; however, it is limited by complications. 2-Mercaptonicotinoyl glycine (Melasyl™) is a new active ingredient targeting melanin synthesis without impairing the tyrosinase enzyme, with proven efficacy and safety. This study assessed the non-inferiority of a new facial depigmenting serum Mela&#xa0;B3<sup>®</sup> (MB3), containing 0.5% 2-mercaptonicotinoyl glycine, <i>versus</i> hydroquinone 4%.</p> Methods <p>This comparative, non-inferiority, randomized, investigator-blind, parallel-group investigation included adult women with mild-to-severe epidermal or mixed facial melasma. Patients received 3-month treatment with MB3 (twice daily) or hydroquinone 4% (once daily) and applied a broad spectrum SPF 50+/UVA tinted sunscreen (twice daily). Evaluations were conducted at day (D)&#xa0;0, D28, D56, and D84 of treatment by a dermatologist and the patients. Non-inferiority analysis was performed at D84 on the Modified Melasma Area and Severity Index (mMASI) (non-inferiority margin 1.3). Efficacy assessments included mMASI, Melasma Quality of Life questionnaire (MELASQoL), and Patient Unique Stigmatization Holistic tool in Dermatology (PUSH-D) scores at each visit. Safety and tolerance were evaluated.</p> Results <p>The study included 109 women (phototypes I–IV; &gt; 80% had phototypes III–IV). At D84, the estimated difference in mMASI score between MB3 and hydroquinone 4% was 0.46 (95% confidence interval − 0.25–1.17). Both groups demonstrated statistically significant improvements on mMASI from D28 <i>versus</i> baseline. The MELASQoL and PUSH-D scores decreased significantly from D28 in both groups (no difference between the groups). Nevertheless, a significant difference in the PUSH-D score was observed at D28 and D56 in favor of MB3. MB3 showed better tolerability <i>versus</i> hydroquinone 4% at D28 with fewer local skin reactions (6.0% <i>versus</i> 21.4%, respectively; <i>p</i> = 0.0286).</p> Conclusion <p>MB3 shows non-inferior efficacy and better tolerability compared with hydroquinone 4%. MB3 is an effective and well-tolerated alternative option for the topical treatment of melasma.</p> Clinical Trial Registration <p>NCT06787846.</p>

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Efficacy and Tolerability of a New Facial 2-Mercaptonicotinoyl Glycine-Containing Depigmenting Serum Versus Hydroquinone 4% over 3-Month Treatment of Facial Melasma

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年6月30日

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  • Thierry Passeron,
  • Delphine Kerob,
  • Guénaëlle Le Dantec,
  • Anne-Laure Demessant-Flavigny,
  • Alessandro R. do Nascimento,
  • Renato Moura,
  • Samir Salah,
  • Mariana Feiges,
  • Erika Fernandez,
  • Andrew Alexis

摘要

Introduction

Topical treatment with hydroquinone 4% and hydroquinone-based preparations is the gold standard of care for melasma; however, it is limited by complications. 2-Mercaptonicotinoyl glycine (Melasyl™) is a new active ingredient targeting melanin synthesis without impairing the tyrosinase enzyme, with proven efficacy and safety. This study assessed the non-inferiority of a new facial depigmenting serum Mela B3® (MB3), containing 0.5% 2-mercaptonicotinoyl glycine, versus hydroquinone 4%.

Methods

This comparative, non-inferiority, randomized, investigator-blind, parallel-group investigation included adult women with mild-to-severe epidermal or mixed facial melasma. Patients received 3-month treatment with MB3 (twice daily) or hydroquinone 4% (once daily) and applied a broad spectrum SPF 50+/UVA tinted sunscreen (twice daily). Evaluations were conducted at day (D) 0, D28, D56, and D84 of treatment by a dermatologist and the patients. Non-inferiority analysis was performed at D84 on the Modified Melasma Area and Severity Index (mMASI) (non-inferiority margin 1.3). Efficacy assessments included mMASI, Melasma Quality of Life questionnaire (MELASQoL), and Patient Unique Stigmatization Holistic tool in Dermatology (PUSH-D) scores at each visit. Safety and tolerance were evaluated.

Results

The study included 109 women (phototypes I–IV; > 80% had phototypes III–IV). At D84, the estimated difference in mMASI score between MB3 and hydroquinone 4% was 0.46 (95% confidence interval − 0.25–1.17). Both groups demonstrated statistically significant improvements on mMASI from D28 versus baseline. The MELASQoL and PUSH-D scores decreased significantly from D28 in both groups (no difference between the groups). Nevertheless, a significant difference in the PUSH-D score was observed at D28 and D56 in favor of MB3. MB3 showed better tolerability versus hydroquinone 4% at D28 with fewer local skin reactions (6.0% versus 21.4%, respectively; p = 0.0286).

Conclusion

MB3 shows non-inferior efficacy and better tolerability compared with hydroquinone 4%. MB3 is an effective and well-tolerated alternative option for the topical treatment of melasma.

Clinical Trial Registration

NCT06787846.