Evidence map›Paper›PMID 39376788›Full record

ArticleClinical, cosmetic and investigational dermatology2024

Efficacy and Safety of Nicotinamide 10%, Associated with Magnesium Ascorbyl Phosphate 5% and Hyaluronic Acid 5%, Compared to Hydroquinone 4% in Women with Facial Melasma: A Randomized, Double-Blind, Controlled Clinical Trial.

Mayla Barbosa, Rebecca Perez de Amorim, Daniel Cassiano, Marina Dias, Ana Flávia de Abreu, Edileia Bagatin, Hélio Amante Miot, Ana Cláudia Cavalcante Espósito

Abstract read
In one paragraph

Article in Clinical, cosmetic and investigational dermatology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Trial
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Mayla BarbosaDepartment of Dermatology, Faculdade de Medicina de Botucatu (UNESP), Botucatu, SP, Brazil.
Rebecca Perez de AmorimDepartment of Dermatology, Faculdade de Medicina de Botucatu (UNESP), Botucatu, SP, Brazil.
Daniel CassianoDepartment of Dermatology, Universidade Federal de São Paulo (UNIFESP), São Paulo, SP, Brazil.
Marina DiasDepartment of Dermatology, Faculdade de Medicina de Botucatu (UNESP), Botucatu, SP, Brazil.
Ana Flávia de AbreuDepartment of Dermatology, Faculdade de Medicina de Botucatu (UNESP), Botucatu, SP, Brazil.ORCID 0000-0003-4169-9068
Edileia BagatinDepartment of Dermatology, Universidade Federal de São Paulo (UNIFESP), São Paulo, SP, Brazil.
Hélio Amante MiotDepartment of Dermatology, Faculdade de Medicina de Botucatu (UNESP), Botucatu, SP, Brazil.ORCID 0000-0002-2596-9294
Ana Cláudia Cavalcante EspósitoDepartment of Dermatology, Faculdade de Medicina de Botucatu (UNESP), Botucatu, SP, Brazil.ORCID 0000-0001-9283-2354

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Nicotinamide has demonstrated efficacy in the treatment of melasma. Topical antioxidants and humectants may enhance its performance. Currently, there is no controlled trial on the combination of 10% nicotinamide, 5% magnesium ascorbyl phosphate, and 5% hyaluronic acid, a dermo-cosmetic compound, in comparison to 4% hydroquinone for the treatment of melasma. This study aimed to explore the tolerability and efficacy of the association of the combined product Methods: A randomized, double-blind trial involving women with facial melasma was conducted. Participants were instructed to apply the combined product (NIC group) twice daily or 4% hydroquinone for 60 days (HQ group) at night and placebo in the morning. Evaluations were performed at inclusion, after 14 and 60 days of treatment, measuring the modified Melasma Area and Severity Index (mMASI), Melasma Quality of Life Scale (MELASQoL), and colorimetric luminosity. The Global Aesthetic Improvement Scale (GAIS) was assessed by a blinded evaluator. Results: Both interventions led to a progressive improvement in mMASI, MELASQoL, and GAIS, without a difference between them on D14 and D60 (p>0.2). For NIC, the mean reduction (95% CI) in mMASI was 16% (8-24%) on D14 and 32% (23-41%) on D60, while for HQ, it was 10% (7-24%) on D14 and 43% (34-52%) on D60. Reduction in colorimetric luminosity was greater in the HQ group at D60 (p=0.01). No serious side effects were identified. Of the initially included 50 patients, one was lost to follow-up in the HQ group on D60, and one withdrew consent from the NIC group, both unrelated to treatment. Conclusion: The association of 10% nicotinamide, 5% magnesium ascorbyl phosphate, and 5% hyaluronic acid was safe and well-tolerated, although its overall clinical efficacy was numerically inferior to 4% hydroquinone. This regimen can be considered for patients with poor tolerability to hydroquinone. Clinical Trial Registration: #RBR-4mkfmr8.

Indexed as

antioxidantshydroquinonehyperpigmentationmelasmanicotinamide

Identifiers

PMID39376788
PMCPMC11457776

What Socratic holds

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LicenceCC BY-NC
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.