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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 10% NAM group(NAM) | Experimental | 10% NAM treatment were twice a day during the entire follow-up period |
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| 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 |
|
| Placebo control group (Ctrl) | Placebo Comparator | received the same course of treatment in the same dosage form that does not contain SA and NAM. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotinamide(NAM)(10%) | Other | The active niacinamide form of vitamin B3, NAM is routinely employed as a pigmentation-reducing agent in melasma treatment protocols |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| melanin index | Use non-invasive skin analyzer to measure the melanin index on the patient's facial skin at each follow-up visit. | From enrollment to week 16 |
| The skin hydration | Use non-invasive skin analyzer to measure the skin hydration on the patient's facial skin at each follow-up visit. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Weihui Zeng | Second Affiliated Hospital of Xi'an Jiaotong University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Xi'an Jiaotong Universi | Xi'an | Shaanxi | 710000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31779194 | Result | 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. | |
| 34844552 | Result | 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. |
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| 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 |
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| 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 |
|
| From enrollment to week 16 |
| 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. | From enrollment to week 16 |
| erythema index | Use non-invasive skin analyzer to measure the erythema index on the patient's facial skin at each follow-up visit. | From enrollment to week 16 |
| Actinic damage (UV spots) | Use VISIA to measure the UV spots on the patient's facial skin at each follow-up visit. | From enrollment to week 16 |
| patient satisfaction evaluation | Patient satisfaction was evaluated as very satisfied, satisfied, relatively satisfied and dissatisfied. | week 16 |
| 32720446 | Result | 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. |
| 31603285 | Result | 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. |
| 31802394 | Result | 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. |
| 30422338 | Result | 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. |
| 28726212 | Result | 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. |
| ID | Term |
|---|---|
| D008548 | Melanosis |
| ID | Term |
|---|---|
| D017495 | Hyperpigmentation |
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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