An interventional study of Concentrated secretome Injection 2mL and Tranexamic acid injection in Melasma, sponsored by Dr.dr.Irma Bernadette, SpKK (K). Recruiting at 2 sites in Indonesia. Open to female participants aged 30 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-24.
Sponsored by Dr.dr.Irma Bernadette, SpKK (K) · Not applicable, Interventional, and Other
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
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
Research subjects were randomized to determine the group for intradermal concentrated secretome injection, triple combination cream, and intradermal tranexamic acid injection.
Subjects will be divided into 30 people per group.
The research evaluation time is 12 weeks. The secretome injection group (A) and the tranexamic acid injection group (C) will be given 0.5% Tretinoin cream for 2 weeks as preparation.
Next, all SP groups A, B, and C will undergo an initial physical examination in the form of a physical examination, clinical photos, mMASI score, MelasQOL-INA, dermoscopy, Wood's lamp, and mexameter.
Group A evaluation will be carried out every 4 weeks, namely weeks 0, 4, 8, 12 with Secretome injections 3 times, namely at weeks 0, 4 and 8. Subjects are given facial wash, sunscreen and 0.5% tretinoin cream at night. day
Group B evaluation will be carried out every 4 weeks, namely weeks 0, 4, 8, 12. Subjects were given facial wash, sunscreen, and Refaquin cream (triple combination) for the night
Group C evaluation will be carried out every 2 weeks, namely weeks 0, 2, 4, 6, 8, and 12. Subjects are given facial wash, sunscreen, and 0.5% tretinoin cream at night.
Each evaluation will be checked:
Data is recorded in research status which is then compiled into a master table. The research results are attached in the form of narratives, tables and graphs. Data were processed statistically using STATA v.16 (StataCorpTM, USA).
The characteristics of the research subjects are presented in the characteristics table. Characteristics with categorical data are presented in the form of frequencies and percentages. Numerical data was subjected to normality analysis using the Kolmogorov Smirnov test and for numerical data with a normal distribution it was presented in the form of mean and standard deviation, while for non-normal distribution it was presented in the median and minimum and maximum values.
Comparison of mMASI scores, melanin index, erythema index, speed of decline between the three research groups, was analyzed using the unpaired t test. Data that is not normally distributed uses an alternative test, namely the Mann Whitney test. Comparison of mMASI scores, melanin index, and erythema index at each examination time with baseline were analyzed using the paired t test. Data that is not normally distributed uses an alternative test, namely the Wilcoxon test. Comparison of the proportion of telangiectasis scores between the intervention and control groups was analyzed using the Chi-square test.
The Pearson test is used to assess the correlation between mMASI and MELASQoL-INA scores if a normal data distribution is obtained, while the Spearman test is used if the data distribution is not normal. The test results obtained are in the form of a correlation coefficient (r) which is in the range -1 and 1. The r value which is in the range 0.1-0.3 indicates the correlation between the two variables is weak, the range 0.4-0.6 indicates a moderate correlation , a range of 0.6-0.9 indicates a strong correlation, and 1 indicates a perfect correlation. The value of statistical significance in the research is determined
170 studies on the registry are indexed under Melanosis; 46 are open to participants now.
This study's planned enrollment of 90 is above the median of 40 across 157 interventional studies indexed under Melanosis.
Browse Melanosis studies →Dr.dr.Irma Bernadette, SpKK (K) is the lead sponsor of 16 studies on the registry; 7 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Concentrated secretome Injection 2mL
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.
Drug: Triple Combination Cream
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.
Drug: Tranexamic acid injection
The secretome used in this research comes from mesenchymal stem cells from adipose tissue produced by IPT RSCM Stem Cell Medical Technology. The secretome produced by mesenchymal stem cells is collected, centrifuged to separate it from debris, and followed by filtration with a 0.22 μm pore filter to ensure sterility. Next, the concentration process is carried out using tangential flow filtration with the Spin-X UF 500® concentrator, packaged, and stored at -80 degrees Celsius. The product used is a sterile product, which is tested for sterility and total protein content. When it is to be used, the secretome is removed from the freezer, warmed (thawing), and injected into the patient according to a predetermined method.
1. Tranexamic acid 25 mg/ml is prepared by taking tranexamic acid in a vial 250 mg/5 ml as much as 0.5 ml (25 mg) using a 1 ml syringe and diluted with 0.5 ml 0.9% NaCl solution just before being injected into the SP. 2. Tranexamic acid 10 mg/ml is prepared by taking 0.2 ml (10 mg) of AT in a 250 mg/5 ml vial using a 1 ml syringe and diluting it with 0.8 ml of 0.9% NaCl solution for a moment. before injection into the Subject 2. Tranexamic acid 10 mg/ml is prepared by taking 0.2 ml (10 mg) of AT in a 250 mg/5 ml vial using a 1 ml syringe and diluting it with 0.9% normal saline (NS) 0.8 ml just before injection into the Subject
1. Apply sunscreen SPF ≥30 in the morning on 2 knuckles 2. Apply triple combination cream (Refaquin) containing hydroquinone 40 mg, tretinoin 0.5 mg, and fluocinolone acetonide 0.1 mg at night all over the face except the area around the eyes, 1 fingertip unit (FTU) or 1 knuckle.
Change of Melasma Severity based on modified Melasma Severity Index (mMASI) score.
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%
Time frame: re-evaluation on day 14, 28, 42, 56 and day 84 of therapy
Change of Melasma Severity based on Patient's Tolerability Assesment (PtGA).
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
Time frame: re-evaluation on day 14, 28, 42, 56 and day 84 of therapy
Change of Melasma Severity based on Dermoscopy
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.
Time frame: re-evaluation on day 84 of therapy
Change of Melasma Severity based on Wood's Lamp
Epidermal Type/ Dermal Typed/ Mixed Typed
Time frame: re-evaluation on day 84 of therapy
Compare Quality Of Life based on MelasQoL Score
based on MelasQoL Score minimum score: 7 maximum score : 70
Time frame: re-evaluation on day 84 of therapy
Change of Melanin Index Based on Mexameter
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%
Time frame: re-evaluation on day 14, 28, 42, 56 and day 84 of therapy
Change of Erytema Index Based on Mexameter
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%
Time frame: re-evaluation on day 14, 28, 42, 56 and day 84 of therapy
Plan to share: Undecided
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Started Feb 2024 (actual). Primary completion is estimated for Mar 2025, 13 months after the start.
Of 33 non-industry interventional studies with no phase under Melanosis, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 18. This study's planned 13 months is above that.
Counting every sponsor, half of 53 studies reached it within 9 months; a quarter within 5 and three quarters within 18.
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Studies of the drug tested here: Tranexamic Acid
Dr.dr.Irma Bernadette, SpKK (K)