Effectiveness and Safety of Pigment Solution Program (PSP) as Adjuvant Therapy in Melasma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Change of Melasma Severity based on Wood's Lamp
研究概览
简要总结
This research is a clinical study with a single-blind randomized clinical trial design (randomized controlled trial) in multicenters at two Dermatology and Venereology Education centers in Indonesia.
This study aims to determine the effectiveness and safety of PSP as adjuvant therapy for melasma.
This research will be attended by 33 research subjects
详细描述
Melasma is one of the most common hyperpigmentary dermatoses, found mostly in Asian or Hispanic people living in tropical areas.
The goal of melasma treatment is to remove existing pigmentation and to inhibit pigmentation. Until now, hydroquinone (HQ) is still used as the Gold Standard for melasma therapy.
Various epidemiological studies calculate the prevalence of melasma, it is estimated that the prevalence of melasma is 1% in the general population and in high risk populations it is 9 - 50%. This large variation is due to differences in skin type, ethnicity, and level of UV exposure
The diagnosis of melasma is based on the clinical picture, namely light to dark brown macules with irregular edges and a distribution that tends to be symmetrical, especially on the face. Supporting examinations can be carried out to determine the degree of melasma and monitor the therapy given.
This research is a clinical study with a single-blind randomized clinical trial design (randomized controlled trial) in multicenters at two Dermatology and Venereology Education centers in Indonesia. The number of samples was 33 divided into 2 groups based on consecutive sampling to obtain subjects who met the eligibility criteria. Then subjects will be allocated into two groups using block randomization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •women aged 30-60 years
- •Fitzpatrick skin phototype IV-V
- •Diagnosis of epidermal, mixed and dermal types of Melasma
排除标准
- •Are pregnant or breastfeeding
- •Use other lightening agents, both oral and topical
- •Allergy to PSP content
- •Use of other topical therapies for skin disorders may interfere with the evaluation of melasma conditions
- •Suffering from other skin diseases such as acne, dermatitis
- •Using hormonal birth control
研究组 & 干预措施
Group 2 (PSP Group)
Group 2, the treatment group, used PSP cleanser, PSP Day Cream and SPF 30 sunscreen in the morning and used Hydroquinone 2% and PSP Night Cream at night and PSP cleanser which was used in the morning and evening before using the cream.
干预措施: Pigment Solution Program (Drug)
结局指标
主要结局
Change of Melasma Severity based on Wood's Lamp
时间窗: re-evaluation on day 84 of therapy
Epidermal Type/ Dermal Typed/ Mixed Typed
Compare Quality Of Life based on MelasQoL Score
时间窗: re-evaluation on day 84 of therapy
based on MelasQoL Score minimum score: 7 maximum score : 70
Change of Melasma Severity based on modified Melasma Severity Index (mMASI) score.
时间窗: re-evaluation on day 28, day 56 and day 84 of therapy
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). 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 Melasma Severity based on Investigator Global Assesment (IGA).
时间窗: re-evaluation on day 28, day 56 and day 84 of therapy
Assessment of response to therapy as follows: * No effect: 0 (no visible change in Pigmentation) * Mild: 1 (decreased visible pigmentation, but still visible boundaries) * Moderate: 2 (obvious decrease in Pigmentation, but still limited visible) * Very good: 3 (disappearance of all visible abnormalities Pigmentation) improvement if there is \>50% improvement from the previous visit worsening if score persists or improvement \<50%
Change of Melanin and Erythema Index Based on Mexameter
时间窗: re-evaluation on day 28, day 56 and day 84 of therapy
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 Melasma Severity based on Dermoscopy
时间窗: re-evaluation on day 84 of therapy
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 Investigator Tolerability Assesment (ITA).
时间窗: re-evaluation on day 84 of therapy
is one method of evaluating patient tolerability of products which is assessed subjectively by investigators. Assessment of patient tolerability as follows: * 0 = no tolerability, * 1 = moderate tolerability, * 2 = good tolerability, * 3 = very good tolerability. tolerability was good if the score improved \>50% from the previous visit worsening if score persists or improvement \<50%
Change of Melasma Severity based on Patient's Tolerability Assesment (PtGA).
时间窗: re-evaluation on day 28, day 56 and day 84 of therapy
one method of evaluating the response to therapy in melasma which is assessed subjectively by the patient. The response to therapy can be assessed as follows * No or slight response: \< 25% improvement * Moderate response: 25% - 50% improvement * Good response: 50% improvement - \< 75% * Excellent response: improvement \> 75% The response is said to be good if the score is above 50% since the previous visit
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, SpKK(K)
Indonesia University