The Efficacy and Safety of a Combined Serum Containing Melasyl™, 10% Niacinamide, Hyaluronic Acid, and Hydroxyethylpiperazine Ethane Sulfonic Acid Following Low-Fluence Q-Switched Nd:YAG 1064 nm Laser Treatment for Melasma and Post-Acne Hyperpigmentation Therapy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Change of Subjective Pain Evaluation
研究概览
简要总结
The goal of this clinical trial is to evaluate the efficacy and safety of a combination serum containing Melasyl™, 10% Niacinamide, Hyaluronic Acid, and HEPES when used as a moisturizer after QS-Nd:YAG 1064 nm low-fluence laser treatment for melasma and post-acne hyperpigmentation.
The study aims to answer the following main questions:
- Does the combination serum reduce hyperpigmented lesions after laser treatment for melasma and post-acne hyperpigmentation?
- Does the serum improve skin hydration following laser therapy for melasma?
- Is the combination serum safe for use after laser treatment, without causing irritation or adverse effects?
Participants will be female patients aged 18-60 years, clinically diagnosed with melasma or post-acne hyperpigmentation (skin types IV and V), who visit the Dermatology & Venereology Outpatient Clinic for QS-Nd:YAG 1064 low-fluence laser treatment. All participants will have undergone a 2-week priming period using either 2% hydroquinone cream or the test serum prior to laser treatment. Written informed consent is required.
Participants will be randomly assigned to receive either the test serum or 2% hydroquinone cream based on a coded allocation. The product will be applied twice daily after facial cleansing, and sunscreen will be used 15 minutes before outdoor activities. Treatment lasts for 2 weeks, with participants recording application times and any adverse effects in a diary. Evaluations-including facial photography, mMASI, mexameter, dermoscopy, Wood's lamp, and PAHPI-will be conducted at baseline and at 1, 2, and 4 weeks post-laser. Erythema and subjective assessment (VAS) will be performed 15 minutes after the laser procedure.
详细描述
This study is a randomized, double-blind, placebo-controlled clinical trial aimed at evaluating the efficacy and safety of a combination serum containing Melasyl™, 10% Niacinamide, Hyaluronic Acid, and HEPES as a moisturizer following QS-Nd:YAG 1064 nm low-fluence laser treatment in patients with melasma and post-acne hyperpigmentation. Medical history, physical examination, and laser procedures will be performed at the Dermatology and Venereology Clinic of Gatot Soebroto Central Army Hospital (RSPAD), Jakarta. Participants will be stratified based on their condition (melasma or post-acne hyperpigmentation) and randomly allocated using coded assignment into two groups. Group 1 (control) will receive 2% hydroquinone cream applied nightly, along with sunscreen with SPF >30 applied every morning. Group 2 (intervention) will receive the combination serum applied twice daily (morning and evening), along with the same SPF >30 sunscreen applied each morning. All products will be applied after facial cleansing, and sunscreen will be used 15 minutes prior to outdoor exposure. The treatment duration is 2 weeks, during which participants will record application times and any adverse effects in a diary. Assessments will be conducted at baseline, and at weeks 1, 2, and 4 post-laser, including standardized facial photography, modified Melasma Area and Severity Index (mMASI), mexameter readings, dermoscopy, Wood's lamp examination, and the Post-Acne Hyperpigmentation Index (PAHPI). Erythema scores and subjective assessments (VAS) will be recorded 15 minutes after the laser procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female, aged 18-60 years.
- •Patients diagnosed with post-acne hyperpigmentation and melasma based on clinical examination and Wood's lamp evaluation, with Fitzpatrick skin types IV and V.
- •Patients visiting the Dermatology and Venereology Outpatient Clinic and scheduled to undergo QS Nd:YAG 1064 nm low-fluence laser treatment.
- •Patients who are currently receiving or have received a priming regimen for at least two weeks prior to the laser procedure, consisting of either 2% hydroquinone cream or a serum containing Niacinamide 10%, Hyaluronic Acid, and HEPES.
- •Willing to participate in the study and provide written informed consent after receiving a complete explanation of the study procedures.
排除标准
- •Pregnant, breastfeeding, or currently taking oral contraceptives at the time of evaluation.
- •History of systemic retinoid use within the past three months.
- •History of or ongoing treatment for hormonal/endocrine disorders or other severe systemic illnesses.
- •Currently undergoing immunosuppressive therapy.
- •Difficulty adhering to treatment protocols.
研究组 & 干预措施
treatment
Participants receive the test serum containing Melasyl™, Niacinamide 10%, Hyaluronic Acid, and HEPES every morning and night, plus SPF >30 sunscreen every morning.
干预措施: a combination serum containing Melasyl™, 10% Niacinamide, Hyaluronic Acid, and HEPES (Drug)
control
Participants receive 2% hydroquinone cream at night and SPF >30 sunscreen every morning.
干预措施: 2% hydroquinone cream (Drug)
结局指标
主要结局
Change of Subjective Pain Evaluation
时间窗: baseline; 1 weeks post QS-Nd:YAG 1064 nm low-fluence laser; 2 weeks post QS-Nd:YAG 1064 nm low-fluence laser and 4 weeks post QS-Nd:YAG 1064 nm low-fluence laser
Assessed using Visual Analog Scale (VAS). Scale range is 0-10, 0 indicates no pain and 10 indicates severe pain
Change of Melasma Severity based on modified Melasma Severity Index (mMASI) score
时间窗: baseline; 1 weeks post QS-Nd:YAG 1064 nm low-fluence laser; 2 weeks post QS-Nd:YAG 1064 nm low-fluence laser and 4 weeks post QS-Nd:YAG 1064 nm low-fluence laser
the range of values for mMASI is between 0 and 24 which can then be divided into mild melasma (0-8), moderate (8-16), and severe (16-24). improvement occurs if the mMASI score decreases by \<50% from the previous visit worsening if score persists or mMASI Score Increase \>50%
Change of the Post-Acne Hyperpigmentation Index (PAHPI) score
时间窗: baseline; 1 weeks post QS-Nd:YAG 1064 nm low-fluence laser; 2 weeks post QS-Nd:YAG 1064 nm low-fluence laser and 4 weeks post QS-Nd:YAG 1064 nm low-fluence laser
On physical examination, the severity of post-inflammatory hyperpigmentation in patients with acne vulgaris was assessed using the Post-Acne Hyperpigmentation Index (PAHPI). The PAHPI score ranges from 6 to 22, with a score of 6 indicating mild post-acne hyperpigmentation and a score of 22 indicating severe post-acne hyperpigmentation.
Change of Eryhtema Score
时间窗: baseline; 1 weeks post QS-Nd:YAG 1064 nm low-fluence laser; 2 weeks post QS-Nd:YAG 1064 nm low-fluence laser and 4 weeks post QS-Nd:YAG 1064 nm low-fluence laser
Based on Clinical Erythema Assessment Scale. Scale range is 0-4, 0 indicates no erythema and 4 indicates severe erythema
Change of Melasma Severity based on Dermoscopy
时间窗: baseline; 1 weeks post QS-Nd:YAG 1064 nm low-fluence laser; 2 weeks post QS-Nd:YAG 1064 nm low-fluence laser and 4 weeks post QS-Nd:YAG 1064 nm low-fluence laser
based on Dermoscopy Telangiectasis score assessment using a 5-point dermoscopy-scale: 0 = No visible capillaries. 1 = Elongated capillaries accompanied by dilation, not visible to the naked eye. 2 = Moderate telangiectasis that is beginning to be visible to the naked eye. 3 = Severe telangiectasis characterized by reduced capillary loops. 4 = Very severe telangiectasis characterized by dilatation and loss of capillary loops.
Change of Melasma Severity based on Wood's Lamp
时间窗: baseline; 1 weeks post QS-Nd:YAG 1064 nm low-fluence laser; 2 weeks post QS-Nd:YAG 1064 nm low-fluence laser and 4 weeks post QS-Nd:YAG 1064 nm low-fluence laser
Epidermal Type/ Dermal Typed/ Mixed Typed
Change of Melanin Index Based on Mexameter
时间窗: baseline; 1 weeks post QS-Nd:YAG 1064 nm low-fluence laser; 2 weeks post QS-Nd:YAG 1064 nm low-fluence laser and 4 weeks post QS-Nd:YAG 1064 nm low-fluence laser
improves if there is a decrease in melanin levels \> 50% from the initial visit It is said to be bad or persistent if there is no decrease in melanin levels or there is a decrease of \<50%
Change of Erytema Index Based on Mexameter
时间窗: baseline; 1 weeks post QS-Nd:YAG 1064 nm low-fluence laser; 2 weeks post QS-Nd:YAG 1064 nm low-fluence laser and 4 weeks post QS-Nd:YAG 1064 nm low-fluence laser
improves if there is a decrease in Erytema levels \> 50% from the initial visit It is said to be bad or persistent if there is no decrease in erythema levels or there is a decrease of \<50%
次要结局
未报告次要终点
研究者
Dr.dr.Irma Bernadette, SpKK (K)
Prof. Dr. dr. Irma Bernadette S. Sitohang, Sp.D.V.E., Subsp.D.K.E. - Head of Cosmetic Dermatology Division, Department of Dermatology and Venereology, Faculty of Medicine, Universitas Indonesia, dr. Cipto Mangunkusumo Hospital, Jakarta, Indonesia
Indonesia University