MelasmaNCT06516419
Development of Products Based on Secretom From Stem Cell Conditioned Medium for Melasma Therapy
A study testing Concentrated secretome Injection 2mL, Tranexamic acid injection and Triple Combination Cream in people with Melasma, run by Dr.dr.Irma Bernadette, SpKK (K) at 2 sites in Indonesia.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 30 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Melasma
- What is being tested?
- Concentrated secretome Injection 2mL, Tranexamic acid injection and Triple Combination Cream
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesIndonesia
- Study dates
- 13 Feb 2024to 30 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
Prof. Dr. dr. Irma Bernadette S. Sitohang, SpKK(K) Sitohang contact
Prof. Dr. dr. Irma Bernadette S. Sitohang, SpKK(K) Sitohang Sitohang contact
Indonesia2 sites, 2 recruiting
- Recruiting
Clinical Research Supporting Unit- Faculty of Medicine, University of Indonesia
Jakarta Pusat, DKI Jakarta, 10430
Prof. Dr. dr. Irma Bernadette S. Sitohang, SpKK(K) Sitohang, +62818130761, irma_bernadette@yahoo.com
- Recruiting
Dr. Cipto Mangunkusumo Hospital
Jakarta Pusat, DKI Jakarta, 10430
Irma Bernadette Sitohang, MD, +62818130761, irma_bernadette@yahoo.com
About this study
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
Read the detailed description
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:
- Physical examination
- mMASI score
- PtGA
- mexameter examination
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
- Conditions
- Melasma
- Being tested
- Concentrated secretome Injection 2mL, Tranexamic acid injection, Triple Combination Cream
- Medical subject headings
- Melanosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Concentrated secretome Injection 2mLDrug
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.
Tranexamic acid injectionDrug
- 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.
- 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
- 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
Triple Combination CreamDrug
- Apply sunscreen SPF ≥30 in the morning on 2 knuckles
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Group A (Secretom group) | Experimental | 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. Receives: Drug: Concentrated secretome Injection 2mL |
| Group B (Triple Combination Group) | Experimental | 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. Receives: Drug: Triple Combination Cream |
| Group C (Tranexamic Acid Group) | Experimental | 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. Receives: Drug: Tranexamic acid injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%
Measured: 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
Measured: 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.
Measured: re-evaluation on day 84 of therapy
Change of Melasma Severity based on Wood's Lamp
Epidermal Type/ Dermal Typed/ Mixed Typed
Measured: 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
Measured: 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%
Measured: 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%
Measured: re-evaluation on day 14, 28, 42, 56 and day 84 of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study start13 Feb 2024
- Primary completion30 Mar 2025 (estimated)
- Study completion30 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelasmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr.dr.Irma Bernadette, SpKK (K)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr.dr.Irma Bernadette, SpKK (K), Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06516419
- Sponsor's protocol ID
- Secretome
- Status last verified
- Jul 2024
- First submitted
- 8 Jul 2024
- Last updated
- 24 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Products Based on Secretom From Stem Cell Conditioned Medium for Melasma Therapy
- ClinicalTrials.gov ID
- NCT06516419
- Acronym / sponsor ID
- Secretome
- Conditions
- Melasma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Dr.dr.Irma Bernadette, SpKK (K)University, hospital or other
- Study start
- 13 Feb 2024 (actual)
- Primary completion
- 30 Mar 2025 (estimated)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 24 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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:
- Physical examination
- mMASI score
- PtGA
- mexameter examination
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A (Secretom group) | Experimental | Drug: Concentrated secretome Injection 2mLGroup 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. |
| Group B (Triple Combination Group) | Experimental | Drug: Triple Combination CreamGroup 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. |
| Group C (Tranexamic Acid Group) | Experimental | Drug: Tranexamic acid injectionGroup 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. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Concentrated secretome Injection 2mLThe 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. | Drug | Group A (Secretom group) |
| Tranexamic acid injection1. 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 | Drug | Group C (Tranexamic Acid Group) |
| Triple Combination Cream1. 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. | Drug | Group B (Triple Combination Group) |
Primary outcome
Change of Melasma Severity based on modified Melasma Severity Index (mMASI) score.
Time frame: 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%
Change of Melasma Severity based on Patient's Tolerability Assesment (PtGA).
Time frame: 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 Dermoscopy
Time frame: 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 Wood's Lamp
Time frame: re-evaluation on day 84 of therapy
Epidermal Type/ Dermal Typed/ Mixed Typed
Compare Quality Of Life based on MelasQoL Score
Time frame: re-evaluation on day 84 of therapy
based on MelasQoL Score minimum score: 7 maximum score : 70
Change of Melanin Index Based on Mexameter
Time frame: 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
Time frame: 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%
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof. Dr. dr. Irma Bernadette S. Sitohang, SpKK(K) Sitohang contact
Prof. Dr. dr. Irma Bernadette S. Sitohang, SpKK(K) Sitohang Sitohang contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Concentrated secretome Injection 2mL, Tranexamic acid injection and Triple Combination Cream in people with Melasma, run by Dr.dr.Irma Bernadette, SpKK (K) at 2 sites in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Prof. Dr. dr. Irma Bernadette S. Sitohang, SpKK(K) Sitohang (+62818130761, irma_bernadette@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Melasma Severity based on modified Melasma Severity Index (mMASI) score. (time frame: re-evaluation on day 14, 28, 42, 56 and day 84 of therapy). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2024.