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

NCT07062120 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2025-07-14

No results posted yet for this study

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

Interventions

OTHER

Nicotinamide(NAM)(10%)

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

OTHER

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

OTHER

Supramolecular salicylic acid simulator

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

OTHER

Nicotinamide simulator

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

Sponsors & Collaborators

  • Second Affiliated Hospital of Xi'an Jiaotong University

    lead OTHER

Principal Investigators

  • Weihui Zeng · Second Affiliated Hospital of Xi'an Jiaotong University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2021-04-01
Completion
2021-04-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07062120 on ClinicalTrials.gov