Development of Products Based on Secretom From Stem Cell Conditioned Medium for Melasma Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Change of Melasma Severity based on Patient's Tolerability Assesment (PtGA).
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 RSCM-FKUI
This study aims to Assess the effectiveness and safety of intradermal concentrated secretome injection therapy, triple combination cream, and intradermal tranexamic acid injection in melasma patients, determine the quality of life profile of melasma patients after triple combination cream therapy in melasma therapy, and determine SOD levels in melasma patients.
This research will be attended by 90 research subjects
详细描述
Melasma is a pigmentation disorder in the form of brownish macules with irregular edges caused by dysfunction of melanogenesis. Melasma occurs more often in women with Fitzpatrick skin types IV-VI, namely those of Asian, Hispanic and African descent, especially on parts of the face that are exposed to sunlight.
The therapeutic modality that is being developed for melasma therapy is the secretome. The secretome is a bioactive molecule secreted by Mesenchymal Stem Cells in a conditioned medium containing a large number of growth factors, cytokines, and various macromolecules, and extracellular vesicles including microvesicles and exosomes that can stimulate various biological reactions, especially in modulating various new tissue formations.
So far there have been no clinical trial studies comparing the application methods of intradermal concentrated secretome injection, triple combination cream, and intradermal tranexamic acid injection as melasma therapy in Indonesia and the quality of life profile of melasma patients tested using the MELASQoL-INA questionnaire is not yet known.
This research is a study using a Randomized Controlled Trial (RCT) design that compares intradermal concentrated secretome injection, triple combination cream, and intradermal injection of tranexamic acid.
This study was single-blind randomized to investigators. The secretome of mesenchymal stem cells from adipose tissue will be produced by IPT Stem Cell Medical Technology RSCM-FKUI, CMU 2 Building, 5th Floor, while research on subjects with melasma will be carried out at the RSCM Dermatology and Venereology Polyclinic
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 diagnosed with melasma.
- •Women without melasma and have areas of skin that are clinically free of lesions for SP control.
- •30-60 years old.
- •Fitzpatrick skin type IV-V.
- •Willing to be a research subject by signing a research consent form (Informed Consent).
排除标准
- •Pregnant and breastfeeding women.
- •Currently using hormonal contraception or have ever used contraception hormones in the last 6 months.
- •Using topical therapy for melasma, for example corticosteroids, tretinoin, hydroquinone, and other therapies that whiten or brighten the skin in the last 2 weeks.
- •Using topical triple combination cream therapy for at least 3 months and did not show significant improvement
- •Using systemic therapy for melasma, for example antioxidants or tranexamic acid in the last 4 weeks.
- •History of superficial peeling therapy in the last 4 weeks.
- •History of deep peeling therapy, laser or mechanical abrasion in the last 6 months.
- •Using drugs that are photosensitizers such as tetracycline, phenytoin, carbamazepine, spironolactone.
- •History of blood clotting disorders or on blood thinning therapy.
- •Allergy to tranexamic acid.
- •Have other skin complaints that may interfere with the evaluation of melasma, for example post-inflammatory hyperpigmentation, Hori's nevus, Ota's nevus, pigmented contact dermatitis, and other pigmentation disorders
- •Difficulty complying with treatment.
研究组 & 干预措施
Group B (Triple Combination Group)
Group B, the treatment group, getting sunscreen cream in the morning and triple combination (Refaquin) cream at night and facial soap that can be used in the morning and evening.
干预措施: Triple Combination Cream (Drug)
Group A (Secretom group)
Group A, the treatment group, used Secretom 2ml Intradermal injection, Sunscreen in the morning and used Tretinoin cream 0,05% at night and cleanser which was used in the morning and evening before using the cream.
干预措施: Concentrated secretome Injection 2mL (Drug)
Group C (Tranexamic Acid Group)
Group C, the treatment group, used Intradermal Injection of Tranexamic Acid 10mg/mL and 25mg/mL split face , Sunscreen in the morning and used Tretinoin cream 0,05% at night and cleanser which was used in the morning and evening before using the cream.
干预措施: Tranexamic acid injection (Drug)
结局指标
主要结局
Change of Melasma Severity based on Patient's Tolerability Assesment (PtGA).
时间窗: re-evaluation on day 14, 28, 42, 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
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
Change of Melasma Severity based on modified Melasma Severity Index (mMASI) score.
时间窗: re-evaluation on day 14, 28, 42, 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). improvement occurs if the mMASI score decreases by \<50% from the previous visit worsening if score persists or mMASI Score Increase \>50%
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 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 Melanin Index Based on Mexameter
时间窗: re-evaluation on day 14, 28, 42, 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 Erytema Index Based on Mexameter
时间窗: re-evaluation on day 14, 28, 42, 56 and day 84 of therapy
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, SpKK(K)
Indonesia University