Efficacy and Safety of 30% Salicylic Acid and 10% Nicotinamide Combined Therapy in Melasma

NCT07062120 | Completed

• 1 other identifier: 2021016
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective, randomized, placebo-controlled study evaluated the synergistic effects of 30% salicylic acid (SA) chemical peels and topical 10% nicotinamide (NAM) in 56 patients with moderate-to-severe melasma. Participants were divided into four groups: placebo control, SA peels alone (every 2 weeks for 8 sessions), NAM cream alone (twice daily for 16 weeks), and combination therapy (SA+NAM). The investigators investigated the efficacy and safety of 30%SA chemical peeling combined with 10% NAM.

Conditions

Melasma

Keywords

Melasma; salicylic acid; nicotinamide; chemical peeling

Outcome Measures

Primary Outcomes (1)

• mMASI score

  The Primary outcomes were pre-defined as mMASI score and percent change in mMASI score, which was calculated as (mMASI at baseline-mMASI after treatment)/ mMASI at baseline × 100% and was graded as recovery (≥90%), obvious improvement (60-89%), improvement (20-59%), and no improvement (\<20%).

  From enrollment to week 16

Secondary Outcomes (6)

• melanin index

  From enrollment to week 16

• The skin hydration

  From enrollment to week 16

• transepidermal water loss

  From enrollment to week 16

• erythema index

  From enrollment to week 16

• Actinic damage (UV spots)

  From enrollment to week 16

Study Arms (4)

30% SSA group(SSA)

EXPERIMENTAL

30% SSA treatment were with 2-week intervals for eight sessions, and the follow-up was conducted 2 weeks after the last session

Other: Supramolecular salicylic acid(SSA) (30%); Other: Nicotinamide simulator

10% NAM group(NAM)

EXPERIMENTAL

10% NAM treatment were twice a day during the entire follow-up period

Other: Nicotinamide(NAM)(10%); Other: Supramolecular salicylic acid simulator

30% SSA plus 10% NAM group (SSA+NAM)

EXPERIMENTAL

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

Other: Nicotinamide(NAM)(10%); Other: Supramolecular salicylic acid(SSA) (30%)

Placebo control group (Ctrl)

PLACEBO COMPARATOR

received the same course of treatment in the same dosage form that does not contain SA and NAM.

Other: Supramolecular salicylic acid simulator; Other: Nicotinamide simulator

Interventions

Nicotinamide(NAM)(10%) OTHER

The active niacinamide form of vitamin B3, NAM is routinely employed as a pigmentation-reducing agent in melasma treatment protocols

10% NAM group(NAM); 30% SSA plus 10% NAM group (SSA+NAM)

Supramolecular salicylic acid(SSA) (30%) OTHER

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

30% SSA group(SSA); 30% SSA plus 10% NAM group (SSA+NAM)

Supramolecular salicylic acid simulator OTHER

the same course of treatment in the same dosage form that does not contain salicylic acid

10% NAM group(NAM); Placebo control group (Ctrl)

Nicotinamide simulator OTHER

the same course of treatment in the same dosage form that does not contain nicotinamide

30% SSA group(SSA); Placebo control group (Ctrl)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Males and nonpregnant females, aged 18-60 years old;
• Diagnosed with melasma;
• Patients with good cognitive function and normal mental status;
• Patients with good communication skills;
• Voluntary participation in the study and signing of informed consent form.

You may not qualify if:

• pregnancy or lactation;
• pigmentation from other causes, such as hormonal dermatitis, cosmetic dermatitis, etc;
• established allergy to SA or NAM;
• active skin infection;
• systemic diseases, such as immunodeficiency disease, diabetes, lupus erythematosus, etc;
• having facial surgery, laser treatment, or whitening products in the past three months;
• neurological or psychiatric disorders.

Sponsors & Collaborators

• Second Affiliated Hospital of Xi'an Jiaotong University: lead

Study Sites (1)

The Second Affiliated Hospital of Xi'an Jiaotong Universi

Xi'an, Shaanxi, 710000, China

Location

Related Publications (7)

• 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.

  PMID: 31779194 BACKGROUND

• 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.

  PMID: 34844552 BACKGROUND

• 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.

  PMID: 32720446 BACKGROUND

• 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.

  PMID: 31603285 BACKGROUND

• 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.

  PMID: 31802394 BACKGROUND

• 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.

  PMID: 30422338 BACKGROUND

• 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.

  PMID: 28726212 BACKGROUND

MeSH Terms

Conditions

Melanosis

Condition Hierarchy (Ancestors)

Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Weihui Zeng

  Second Affiliated Hospital of Xi'an Jiaotong University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 29, 2025
• First Posted: July 14, 2025
• Study Start: January 1, 2021
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2021
• Last Updated: July 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)