Melasma
Conditions
Keywords
Melasma, salicylic acid, nicotinamide, chemical peeling
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.
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.
Interventions
OTHERNicotinamide(NAM)(10%)
The active niacinamide form of vitamin B3, NAM is routinely employed as a pigmentation-reducing agent in melasma treatment protocols
OTHERSupramolecular 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
OTHERSupramolecular salicylic acid simulator
the same course of treatment in the same dosage form that does not contain salicylic acid
OTHERNicotinamide simulator
the same course of treatment in the same dosage form that does not contain nicotinamide
Sponsors
Second Affiliated Hospital of Xi'an Jiaotong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Males and nonpregnant females, aged 18-60 years old; 2. Diagnosed with melasma; 3. Patients with good cognitive function and normal mental status; 4. Patients with good communication skills; 5. Voluntary participation in the study and signing of informed consent form.
Exclusion criteria
1. pregnancy or lactation; 2. pigmentation from other causes, such as hormonal dermatitis, cosmetic dermatitis, etc; 3. established allergy to SA or NAM; 4. active skin infection; 5. systemic diseases, such as immunodeficiency disease, diabetes, lupus erythematosus, etc; 6. having facial surgery, laser treatment, or whitening products in the past three months; 7. neurological or psychiatric disorders.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| mMASI score | 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
| Measure | Time frame | Description |
|---|---|---|
| melanin index | 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. |
| The skin hydration | 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. |
| transepidermal water loss | 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. |
| erythema index | 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. |
| Actinic damage (UV spots) | From enrollment to week 16 | Use VISIA to measure the UV spots on the patient's facial skin at each follow-up visit. |
| patient satisfaction evaluation | week 16 | Patient satisfaction was evaluated as very satisfied, satisfied, relatively satisfied and dissatisfied. |
Countries
China
Outcome results
None listed