Efficacy of Platelet-rich Plasma in Treatment of Melasma
Primary Purpose
Melasma
Status
Completed
Phase
Phase 2
Locations
Mexico
Study Type
Interventional
Intervention
Platelet-Rich Plasma
Sponsored by
About this trial
This is an interventional treatment trial for Melasma focused on measuring Platelet-rich plasma
Eligibility Criteria
Inclusion Criteria:
- Previous diagnosis of melasma
- History of pregnancy with a time greater than 6 months
- Informed consent
Exclusion Criteria:
- In lactation period
- History of skin cancer
- History of liver, thyroid diseases
- With active acne lesions and traumatic lesions on the face
- PRP pre-treatmentPre-treatment for melasma with less than 6 months
- Hb values <10 g / dL or platelet count <105x109 / L
Sites / Locations
- Western Medical Center, Mexican Institute of Social Security
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Application of platelet-rich plasma
Arm Description
The patients received three sessions of PRP application, at intervals of 15 days between each of them. It was applied by means of a 32G needle to introduce the PRP by means of superficial micro-injections via the mesotherapy technique (approximately 1.5-2.0 mm deep) and it was deposited in the papillary dermis of the rosotro.
Outcomes
Primary Outcome Measures
Change of the severity of melasma.
First divide the face into four regions: front (F), right malar (MR), left malar (ML), and chin (CH), which corresponds to 30%, 30%, 30% and 10% , respectively, of the total area(A) of the face. Subsequently, the area involved in each region is evaluated, assigning values from 1 to 6, depending on whether it affects: less than 10%; 10 to 29%; 30 to 49%; 50 to 69%; 70 to 89%; or 90 to 100%. A score is also assigned according to the darkening of the pigmentation (D): absent (0); mild (1); moderate (2); marked (3) or maximum (4). Finally, following this same scale, a value is assigned according to the homogeneity of the pigmentation (H).
The following equation is used to calculate this index:
The Melasma Area and Severity Index= 0.3 (DF + HF) AF+ 0.3 (DMR + HMR) AMR + 0.3 (DML + HML) AML + 0.1 (DCH + HCH) ACH
The range is 0-48, although it is strictly an aesthetic problem, the higher the score, the greater the affectation. This scale was applied before and after the treatment.
Comparison of histological analysis
For this analysis, the obtained samples were fixed by 10% formalin and cuts of 6 μm were made. Hematoxylin-eosin staining was used for the visualization of melanophages in the dermis, cutaneous atrophy, solar elastosis and inflammatory infiltrate. Fontana-Masson stain to evaluate the pigmentation, focality of the pigmentation, distribution and absence of pigment in the papillary dermis.
Biopsy was taken at the beginning of the study and at the end.
Type of melasma by dermatoscopy
It was performed using a dermatoscope (DermLite DL3N brand) with polarized light. Pictures were taken, (with Canon Powershot G12 camera) of the most characteristic part of the lesion, either in front, cheekbones or jaw. The photograph was taken before and after starting the treatment of the same anatomical site on both occasions. The melasma was classified according to the depth in: epidermal (regular and brown pigment is appreciated), dermal (regularity is lost and a color between blue and gray is seen) and mixed (combinations of these two). Two researchers were in charge of performing the dermatoscopy and the qualitative measurement of it.
Amount of melasma by dermatoscopy
Photographs were compared by dermatoscopy of the most characteristic part of the lesion before and after treatment. Categorizing these photographs in: 0 (without appreciable lesions), 1 (discolorations and slight presence of pigment), 2 (scattered pigment points) and 3 (pigment points together).
Density of melasma by dermatoscopy
Photographs were compared by dermatoscopy of the most characteristic part of the lesion before and after treatment. Categorizing these photographs in: 1 (brown pigment), 2 (gray-blue) or 3 (dark brown / black).
Presence or not of telangiectasias.
Photographs were compared by dermatoscopy of the most characteristic part of the lesion before and after treatment. In search of telangiectasias. Two researchers were in charge of performing the dermatoscopy and the qualitative measurement of it.
Secondary Outcome Measures
change in the quality of life: Sp-MELASQOL
Melasma Quality of Life scale (MELASQOL) is a useful and objective tool to assess the quality of life of patients. In this protocol, the Sp-MELASQOL will be used, since it is the version in Spanish validated by Domínguez and cols, for the Latin American population. Which consists of 10 questions, with a score for each question from 1 to 7 points, where 1 = never and 7 = always.
The results range from 7-70 points, the higher the score indicated, the lower the quality of life presented by the patients.
We compare the results obtained before and after the intervention.
Full Information
NCT ID
NCT03674203
First Posted
September 13, 2018
Last Updated
January 24, 2019
Sponsor
Instituto Mexicano del Seguro Social
1. Study Identification
Unique Protocol Identification Number
NCT03674203
Brief Title
Efficacy of Platelet-rich Plasma in Treatment of Melasma
Official Title
Efficacy of Platelet-rich Plasma in Treatment of Melasma
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
May 31, 2018 (Actual)
Study Completion Date
July 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Mexicano del Seguro Social
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The application of Platelet Rich Plasma (PRP) on three occasions with an interval of 15 days between each one, is related to a decrease in the intensity of the spots and improvement in the quality of the skin of patients with melasma.
Detailed Description
832/5000 Objective: To evaluate the effect of PRP for Melasma treatment. Material and methods: Prospective cohort with therapeutic intervention. Patients, female, with melasma were included. Changes in the melanin concentration of the face (MASI), degree of satisfaction (MELASQOL) and histological changes were clinically evaluated.
The Sp-MELASQOL questionnaire, Fitzpatrick and MASI scales were applied, and photographs were taken with ambient light and with Wood's light with the Janus-II General Model. The patients were evaluated and classified, before and after the treatment by means of dermatoscopy, which was performed using a dermatoscope with polarized light (DermLite DL3N®), which allows an increase from 6 to 400X.
The dermatoscopy reported the findings of: Quantity, Density and Depth of melasma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melasma
Keywords
Platelet-rich plasma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
A prospective cohort study with therapeutic intervention for one year. We included patients older than 18 years with a diagnosis of melanoma and a history of pregnancy with a time greater than 6 months, who were not in the period of lactation, with no history of skin cancer, with a history of liver, thyroid or injury, of acne and traumatic injuries on the face, in addition, with no work history of PRP. The patients received three sessions of PRP application, at intervals of 15 days between each of them.
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Application of platelet-rich plasma
Arm Type
Experimental
Arm Description
The patients received three sessions of PRP application, at intervals of 15 days between each of them. It was applied by means of a 32G needle to introduce the PRP by means of superficial micro-injections via the mesotherapy technique (approximately 1.5-2.0 mm deep) and it was deposited in the papillary dermis of the rosotro.
Intervention Type
Biological
Intervention Name(s)
Platelet-Rich Plasma
Intervention Description
1 ml of PRP was distributed in the papillary dermis of the face, repeating the dose at 15 and 30 days.
Primary Outcome Measure Information:
Title
Change of the severity of melasma.
Description
First divide the face into four regions: front (F), right malar (MR), left malar (ML), and chin (CH), which corresponds to 30%, 30%, 30% and 10% , respectively, of the total area(A) of the face. Subsequently, the area involved in each region is evaluated, assigning values from 1 to 6, depending on whether it affects: less than 10%; 10 to 29%; 30 to 49%; 50 to 69%; 70 to 89%; or 90 to 100%. A score is also assigned according to the darkening of the pigmentation (D): absent (0); mild (1); moderate (2); marked (3) or maximum (4). Finally, following this same scale, a value is assigned according to the homogeneity of the pigmentation (H).
The following equation is used to calculate this index:
The Melasma Area and Severity Index= 0.3 (DF + HF) AF+ 0.3 (DMR + HMR) AMR + 0.3 (DML + HML) AML + 0.1 (DCH + HCH) ACH
The range is 0-48, although it is strictly an aesthetic problem, the higher the score, the greater the affectation. This scale was applied before and after the treatment.
Time Frame
one year
Title
Comparison of histological analysis
Description
For this analysis, the obtained samples were fixed by 10% formalin and cuts of 6 μm were made. Hematoxylin-eosin staining was used for the visualization of melanophages in the dermis, cutaneous atrophy, solar elastosis and inflammatory infiltrate. Fontana-Masson stain to evaluate the pigmentation, focality of the pigmentation, distribution and absence of pigment in the papillary dermis.
Biopsy was taken at the beginning of the study and at the end.
Time Frame
one year
Title
Type of melasma by dermatoscopy
Description
It was performed using a dermatoscope (DermLite DL3N brand) with polarized light. Pictures were taken, (with Canon Powershot G12 camera) of the most characteristic part of the lesion, either in front, cheekbones or jaw. The photograph was taken before and after starting the treatment of the same anatomical site on both occasions. The melasma was classified according to the depth in: epidermal (regular and brown pigment is appreciated), dermal (regularity is lost and a color between blue and gray is seen) and mixed (combinations of these two). Two researchers were in charge of performing the dermatoscopy and the qualitative measurement of it.
Time Frame
one year
Title
Amount of melasma by dermatoscopy
Description
Photographs were compared by dermatoscopy of the most characteristic part of the lesion before and after treatment. Categorizing these photographs in: 0 (without appreciable lesions), 1 (discolorations and slight presence of pigment), 2 (scattered pigment points) and 3 (pigment points together).
Time Frame
one year
Title
Density of melasma by dermatoscopy
Description
Photographs were compared by dermatoscopy of the most characteristic part of the lesion before and after treatment. Categorizing these photographs in: 1 (brown pigment), 2 (gray-blue) or 3 (dark brown / black).
Time Frame
one year
Title
Presence or not of telangiectasias.
Description
Photographs were compared by dermatoscopy of the most characteristic part of the lesion before and after treatment. In search of telangiectasias. Two researchers were in charge of performing the dermatoscopy and the qualitative measurement of it.
Time Frame
one year
Secondary Outcome Measure Information:
Title
change in the quality of life: Sp-MELASQOL
Description
Melasma Quality of Life scale (MELASQOL) is a useful and objective tool to assess the quality of life of patients. In this protocol, the Sp-MELASQOL will be used, since it is the version in Spanish validated by Domínguez and cols, for the Latin American population. Which consists of 10 questions, with a score for each question from 1 to 7 points, where 1 = never and 7 = always.
The results range from 7-70 points, the higher the score indicated, the lower the quality of life presented by the patients.
We compare the results obtained before and after the intervention.
Time Frame
one year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Previous diagnosis of melasma
History of pregnancy with a time greater than 6 months
Informed consent
Exclusion Criteria:
In lactation period
History of skin cancer
History of liver, thyroid diseases
With active acne lesions and traumatic lesions on the face
PRP pre-treatmentPre-treatment for melasma with less than 6 months
Hb values <10 g / dL or platelet count <105x109 / L
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clotilde Fuentes, pHD
Organizational Affiliation
Instituto Mexicano del Seguro Social
Official's Role
Principal Investigator
Facility Information:
Facility Name
Western Medical Center, Mexican Institute of Social Security
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44340
Country
Mexico
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Efficacy of Platelet-rich Plasma in Treatment of Melasma
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