Efficacy and Safety of 30% Salicylic Acid and 10% Nicotinamide Combined Therapy in Melasma
NCT ID: NCT07062120
Last Updated: 2025-07-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
56 participants
INTERVENTIONAL
2021-01-01
2021-04-01
Brief Summary
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Detailed Description
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Methods: 56 moderate-to-severe melasma patients were enrolled and randomly assigned into the control group, SA group, NAM group, and SA+NAM group. SA treatment was given at an interval of 2 weeks for 8 treatment sessions (week 0, 2, 4, 6, 8, 10, 12, 14). NAM was applied twice a day for 16w. Photos, mMASI score, and skin indices (TEWL, skin hydration, melanin index, erythema index, red areas score, and UV spots score) were assessed at 0, 2, 4, 6, 8,10,12, and 14 weeks. Side effects, efficacy and satisfactory scores were recorded.
Limitations: Retrospective single-center design and small sample size.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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30% SSA group(SSA)
30% SSA treatment were with 2-week intervals for eight sessions, and the follow-up was conducted 2 weeks after the last session
Supramolecular salicylic acid(SSA) (30%)
Salicylic acid, a superficial chemical peel, has been widely used in treating melasma. Breakthroughs in supramolecular design have addressed its irritancy profile through engineered SA complexes with improved water dispersibility
Nicotinamide simulator
the same course of treatment in the same dosage form that does not contain nicotinamide
10% NAM group(NAM)
10% NAM treatment were twice a day during the entire follow-up period
Nicotinamide(NAM)(10%)
The active niacinamide form of vitamin B3, NAM is routinely employed as a pigmentation-reducing agent in melasma treatment protocols
Supramolecular salicylic acid simulator
the same course of treatment in the same dosage form that does not contain salicylic acid
30% SSA plus 10% NAM group (SSA+NAM)
30% SSA treatment were with 2-week intervals for eight sessions, and 10% NAM treatment were twice a day during the entire follow-up period
Nicotinamide(NAM)(10%)
The active niacinamide form of vitamin B3, NAM is routinely employed as a pigmentation-reducing agent in melasma treatment protocols
Supramolecular salicylic acid(SSA) (30%)
Salicylic acid, a superficial chemical peel, has been widely used in treating melasma. Breakthroughs in supramolecular design have addressed its irritancy profile through engineered SA complexes with improved water dispersibility
Placebo control group (Ctrl)
received the same course of treatment in the same dosage form that does not contain SA and NAM.
Supramolecular salicylic acid simulator
the same course of treatment in the same dosage form that does not contain salicylic acid
Nicotinamide simulator
the same course of treatment in the same dosage form that does not contain nicotinamide
Interventions
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Nicotinamide(NAM)(10%)
The active niacinamide form of vitamin B3, NAM is routinely employed as a pigmentation-reducing agent in melasma treatment protocols
Supramolecular salicylic acid(SSA) (30%)
Salicylic acid, a superficial chemical peel, has been widely used in treating melasma. Breakthroughs in supramolecular design have addressed its irritancy profile through engineered SA complexes with improved water dispersibility
Supramolecular salicylic acid simulator
the same course of treatment in the same dosage form that does not contain salicylic acid
Nicotinamide simulator
the same course of treatment in the same dosage form that does not contain nicotinamide
Eligibility Criteria
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Inclusion Criteria
2. Diagnosed with melasma;
3. Patients with good cognitive function and normal mental status;
4. Patients with good communication skills;
5. Voluntary participation in the study and signing of informed consent form.
Exclusion Criteria
2. pigmentation from other causes, such as hormonal dermatitis, cosmetic dermatitis, etc;
3. established allergy to SA or NAM;
4. active skin infection;
5. systemic diseases, such as immunodeficiency disease, diabetes, lupus erythematosus, etc;
6. having facial surgery, laser treatment, or whitening products in the past three months;
7. neurological or psychiatric disorders.
18 Years
60 Years
ALL
No
Sponsors
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Second Affiliated Hospital of Xi'an Jiaotong University
OTHER
Responsible Party
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Weihui Zeng
Professor
Principal Investigators
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Weihui Zeng
Role: STUDY_CHAIR
Second Affiliated Hospital of Xi'an Jiaotong University
Locations
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The Second Affiliated Hospital of Xi'an Jiaotong Universi
Xi'an, Shaanxi, China
Countries
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References
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Fania L, Mazzanti C, Campione E, Candi E, Abeni D, Dellambra E. Role of Nicotinamide in Genomic Stability and Skin Cancer Chemoprevention. Int J Mol Sci. 2019 Nov 26;20(23):5946. doi: 10.3390/ijms20235946.
Madaan P, Sikka P, Malik DS. Cosmeceutical Aptitudes of Niacinamide: A Review. Recent Adv Antiinfect Drug Discov. 2021;16(3):196-208. doi: 10.2174/2772434416666211129105629.
Searle T, Al-Niaimi F, Ali FR. The top 10 cosmeceuticals for facial hyperpigmentation. Dermatol Ther. 2020 Nov;33(6):e14095. doi: 10.1111/dth.14095. Epub 2020 Sep 4.
Spierings NMK. Melasma: A critical analysis of clinical trials investigating treatment modalities published in the past 10 years. J Cosmet Dermatol. 2020 Jun;19(6):1284-1289. doi: 10.1111/jocd.13182. Epub 2019 Oct 11.
McKesey J, Tovar-Garza A, Pandya AG. Melasma Treatment: An Evidence-Based Review. Am J Clin Dermatol. 2020 Apr;21(2):173-225. doi: 10.1007/s40257-019-00488-w.
Kwon SH, Na JI, Choi JY, Park KC. Melasma: Updates and perspectives. Exp Dermatol. 2019 Jun;28(6):704-708. doi: 10.1111/exd.13844. Epub 2018 Dec 21.
Ogbechie-Godec OA, Elbuluk N. Melasma: an Up-to-Date Comprehensive Review. Dermatol Ther (Heidelb). 2017 Sep;7(3):305-318. doi: 10.1007/s13555-017-0194-1. Epub 2017 Jul 19.
Other Identifiers
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2021016
Identifier Type: -
Identifier Source: org_study_id
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