Efficacy and Tolerability of a New Facial 2-Mercaptonicotinoyl Glycine-Containing Depigmenting Serum Versus Hydroquinone 4% over 3-Month Treatment of Facial Melasma
Abstract 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 tyr...
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Adis, Springer Healthcare
2025-06-01
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| Series: | Dermatology and Therapy |
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| Online Access: | https://doi.org/10.1007/s13555-025-01473-4 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Thierry Passeron |
| collection | DOAJ |
| description | Abstract 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. |
| format | Article |
| id | doaj-art-53ec514b410749ac8e4b7f8c1c08c569 |
| institution | Kabale University |
| issn | 2193-8210 2190-9172 |
| language | English |
| publishDate | 2025-06-01 |
| publisher | Adis, Springer Healthcare |
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| series | Dermatology and Therapy |
| spelling | doaj-art-53ec514b410749ac8e4b7f8c1c08c5692025-08-20T03:42:23ZengAdis, Springer HealthcareDermatology and Therapy2193-82102190-91722025-06-011592379239010.1007/s13555-025-01473-4Efficacy and Tolerability of a New Facial 2-Mercaptonicotinoyl Glycine-Containing Depigmenting Serum Versus Hydroquinone 4% over 3-Month Treatment of Facial MelasmaThierry Passeron0Delphine Kerob1Guénaëlle Le Dantec2Anne-Laure Demessant-Flavigny3Alessandro R. do Nascimento4Renato Moura5Samir Salah6Mariana Feiges7Erika Fernandez8Andrew Alexis9Department of Dermatology, Côte d’Azur University, Nice University Hospital CenterLa Roche-Posay Laboratoire Dermatologique, La Roche Posay InternationalLa Roche-Posay Laboratoire Dermatologique, La Roche Posay InternationalLa Roche-Posay Laboratoire Dermatologique, La Roche Posay InternationalCentre International de Développement Pharmaceutique (CIDP)Centre International de Développement Pharmaceutique (CIDP)La Roche-Posay Laboratoire Dermatologique, La Roche Posay InternationalL’Oreal BrazilL’Oreal BrazilDepartment of Dermatology, Weill Cornell Medical CollegeAbstract 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.https://doi.org/10.1007/s13555-025-01473-42-Mercaptonicotinoyl glycineDepigmenting serumHydroquinoneMelasmaTopical treatment |
| spellingShingle | 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 Efficacy and Tolerability of a New Facial 2-Mercaptonicotinoyl Glycine-Containing Depigmenting Serum Versus Hydroquinone 4% over 3-Month Treatment of Facial Melasma Dermatology and Therapy 2-Mercaptonicotinoyl glycine Depigmenting serum Hydroquinone Melasma Topical treatment |
| title | Efficacy and Tolerability of a New Facial 2-Mercaptonicotinoyl Glycine-Containing Depigmenting Serum Versus Hydroquinone 4% over 3-Month Treatment of Facial Melasma |
| title_full | Efficacy and Tolerability of a New Facial 2-Mercaptonicotinoyl Glycine-Containing Depigmenting Serum Versus Hydroquinone 4% over 3-Month Treatment of Facial Melasma |
| title_fullStr | Efficacy and Tolerability of a New Facial 2-Mercaptonicotinoyl Glycine-Containing Depigmenting Serum Versus Hydroquinone 4% over 3-Month Treatment of Facial Melasma |
| title_full_unstemmed | Efficacy and Tolerability of a New Facial 2-Mercaptonicotinoyl Glycine-Containing Depigmenting Serum Versus Hydroquinone 4% over 3-Month Treatment of Facial Melasma |
| title_short | Efficacy and Tolerability of a New Facial 2-Mercaptonicotinoyl Glycine-Containing Depigmenting Serum Versus Hydroquinone 4% over 3-Month Treatment of Facial Melasma |
| title_sort | efficacy and tolerability of a new facial 2 mercaptonicotinoyl glycine containing depigmenting serum versus hydroquinone 4 over 3 month treatment of facial melasma |
| topic | 2-Mercaptonicotinoyl glycine Depigmenting serum Hydroquinone Melasma Topical treatment |
| url | https://doi.org/10.1007/s13555-025-01473-4 |
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