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NCT Number: NCT07062120

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Second Affiliated Hospital of Xi'an Jiaotong Universi

Xi'an, Shaanxi, 710000, China

About this study

Background:Melasma is a common skin disease manifested as brown patches with symmetrical distribution and irregular boundaries. Chemical peeling with salicylic acid (SA) is widely used in the treatment of melasma. Nicotinamide (NAM) is a common whitening agent and has a good effect in the treatment of melasma. In the present study, the investigators investigated the efficacy and safety of 30%SA chemical peeling combined with 10% NAM.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Nicotinamide(NAM)(10%)

Other

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%)

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

Supramolecular salicylic acid simulator

Other

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

Nicotinamide simulator

Other

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

Primary outcomes

  1. mMASI score

    Time frame: From enrollment to week 16

    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%).

Secondary outcomes

  1. melanin index

    Time frame: From enrollment to week 16

    Use non-invasive skin analyzer to measure the melanin index on the patient's facial skin at each follow-up visit.

  2. The skin hydration

    Time frame: From enrollment to week 16

    Use non-invasive skin analyzer to measure the skin hydration on the patient's facial skin at each follow-up visit.

  3. transepidermal water loss

    Time frame: From enrollment to week 16

    Use non-invasive skin analyzer to measure the transepidermal water loss on the patient's facial skin at each follow-up visit.

  4. erythema index

    Time frame: From enrollment to week 16

    Use non-invasive skin analyzer to measure the erythema index on the patient's facial skin at each follow-up visit.

  5. Actinic damage (UV spots)

    Time frame: From enrollment to week 16

    Use VISIA to measure the UV spots on the patient's facial skin at each follow-up visit.

  6. patient satisfaction evaluation

    Time frame: week 16

    Patient satisfaction was evaluated as very satisfied, satisfied, relatively satisfied and dissatisfied.

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital of Xi'an Jiaotong University

Other

Registry information

Official study title

Efficacy and Safety of 30% Salicylic Acid and 10% Nicotinamide Combined Therapy in Melasma: A Randomized Placebo Controlled Study

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jul 14, 2025
Registry last updated
Jul 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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