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

Xi'an Jiaotong University

Status: Completed

Conditions: Melasma

Treatments: Other: Nicotinamide(NAM)(10%); Other: Nicotinamide simulator; Other: Supramolecular salicylic acid(SSA) (30%); Other: Supramolecular salicylic acid simulator

Study type: Interventional

Funder types: Other

Identifiers

NCT07062120

2021016

Details and patient eligibility

About

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.

Full 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.

Enrollment: 56 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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56 participants in 4 patient groups, including a placebo group

30% SSA group(SSA)

Experimental group

Description:

30% SSA treatment were with 2-week intervals for eight sessions, and the follow-up was conducted 2 weeks after the last session

Treatment:

Other: Supramolecular salicylic acid(SSA) (30%)

Other: Nicotinamide simulator

10% NAM group(NAM)

Experimental group

Description:

10% NAM treatment were twice a day during the entire follow-up period

Treatment:

Other: Supramolecular salicylic acid simulator

Other: Nicotinamide(NAM)(10%)

30% SSA plus 10% NAM group (SSA+NAM)

Experimental group

Description:

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

Treatment:

Other: Supramolecular salicylic acid(SSA) (30%)

Other: Nicotinamide(NAM)(10%)

Placebo control group (Ctrl)

Placebo Comparator group

Description:

received the same course of treatment in the same dosage form that does not contain SA and NAM.

Treatment:

Other: Supramolecular salicylic acid simulator

Other: Nicotinamide simulator