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AzTrials

MelasmaNCT07062120

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

A study testing Nicotinamide(NAM)(10%), Supramolecular salicylic acid(SSA) (30%) and Supramolecular salicylic acid simulator in people with Melasma, run by Second Affiliated Hospital of Xi'an Jiaotong University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Melasma
What is being tested?
Nicotinamide(NAM)(10%), Supramolecular salicylic acid(SSA) (30%) and Supramolecular salicylic acid simulator
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
56 participants
Where
1 siteChina
Study dates
1 Jan 2021to 1 Apr 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The Second Affiliated Hospital of Xi'an Jiaotong Universi

    Xi'an, Shaanxi, 710000

Other trials in China

About this study

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

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.

Read the detailed description

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.

Conditions
Melasma
Being tested
Nicotinamide(NAM)(10%), Supramolecular salicylic acid(SSA) (30%), Supramolecular salicylic acid simulator, Nicotinamide simulator
Keywords
Melasma, salicylic acid, nicotinamide, chemical peeling
Medical subject headings
Melanosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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 simulatorOther

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

  • Nicotinamide simulatorOther

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

Study groups in NCT07062120
Study groupRoleWhat they receive
30% SSA group(SSA)Experimental30% SSA treatment were with 2-week intervals for eight sessions, and the follow-up was conducted 2 weeks after the last session
Receives: Other: Supramolecular salicylic acid(SSA) (30%); Other: Nicotinamide simulator
10% NAM group(NAM)Experimental10% NAM treatment were twice a day during the entire follow-up period
Receives: Other: Nicotinamide(NAM)(10%); Other: Supramolecular salicylic acid simulator
30% SSA plus 10% NAM group (SSA+NAM)Experimental30% SSA treatment were with 2-week intervals for eight sessions, and 10% NAM treatment were twice a day during the entire follow-up period
Receives: Other: Nicotinamide(NAM)(10%); Other: Supramolecular salicylic acid(SSA) (30%)
Placebo control group (Ctrl)Placebo comparatorreceived the same course of treatment in the same dosage form that does not contain SA and NAM.
Receives: Other: Supramolecular salicylic acid simulator; Other: Nicotinamide simulator

What is being measured

The primary outcome is the main question the study is designed to answer.

  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%).

    Measured: From enrollment to week 16

Secondary outcomes (6)

  1. melanin index

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

    Measured: From enrollment to week 16

  2. The skin hydration

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

    Measured: From enrollment to week 16

  3. transepidermal water loss

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

    Measured: From enrollment to week 16

  4. erythema index

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

    Measured: From enrollment to week 16

  5. Actinic damage (UV spots)

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

    Measured: From enrollment to week 16

  6. patient satisfaction evaluation

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

    Measured: week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2025
  2. Study start1 Jan 2021
  3. Primary completion1 Apr 2021
  4. Study completion1 Apr 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07062120
Sponsor's protocol ID
2021016
Status last verified
Jul 2025
First submitted
29 Jun 2025
Last updated
14 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 31779194

  • 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.

    PubMed 34844552

  • 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.

    PubMed 32720446

  • 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.

    PubMed 31603285

  • 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.

    PubMed 31802394

  • 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.

    PubMed 30422338

  • 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.

    PubMed 28726212

Questions about this trial

What is this clinical trial studying?

A study testing Nicotinamide(NAM)(10%), Supramolecular salicylic acid(SSA) (30%) and Supramolecular salicylic acid simulator in people with Melasma, run by Second Affiliated Hospital of Xi'an Jiaotong University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

mMASI score (time frame: From enrollment to week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07062120, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2025.

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