Ignite Creation Date:
2024-10-25 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06516419
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-08
Brief Title:
Development of Products Based on Secretom From Stem Cell Conditioned Medium for Melasma Therapy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Development of Products Based on Secretom From Stem Cell Conditioned Medium for Melasma Therapy
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
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 05 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 Woods 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 05 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 05 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 v16 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 01-03 indicates the correlation between the two variables is weak the range 04-06 indicates a moderate correlation a range of 06-09 indicates a strong correlation and 1 indicates a perfect correlation The value of statistical significance in the research is determined
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 05 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 Woods 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 05 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 05 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 v16 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 01-03 indicates the correlation between the two variables is weak the range 04-06 indicates a moderate correlation a range of 06-09 indicates a strong correlation and 1 indicates a perfect correlation The value of statistical significance in the research is determined
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None