Efficacy of Platelet-rich Plasma in Treatment of Melasma

NCT03674203 | Completed Phase 2 DMC

• 1 other identifier: R-2015-1301-88.
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Melasma

Keywords

Platelet-rich plasma

Outcome Measures

Primary Outcomes (6)

• 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.

  one year

• 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.

  one year

• 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.

  one year

• 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).

  one year

• 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).

  one year

• 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.

  one year

Secondary Outcomes (1)

• change in the quality of life: Sp-MELASQOL

  one year

Study Arms (1)

Application of platelet-rich plasma

EXPERIMENTAL

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.

Biological: Platelet-Rich Plasma

Interventions

Platelet-Rich Plasma BIOLOGICAL

1 ml of PRP was distributed in the papillary dermis of the face, repeating the dose at 15 and 30 days.

Application of platelet-rich plasma

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Previous diagnosis of melasma
• History of pregnancy with a time greater than 6 months
• Informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto Mexicano del Seguro Social: lead

Study Sites (1)

Western Medical Center, Mexican Institute of Social Security

Guadalajara, Jalisco, 44340, Mexico

Location

MeSH Terms

Conditions

Melanosis

Condition Hierarchy (Ancestors)

Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Clotilde Fuentes, pHD

  Instituto Mexicano del Seguro Social

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: 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.

Study Record Dates

• First Submitted: September 13, 2018
• First Posted: September 17, 2018
• Study Start: May 1, 2017
• Primary Completion: May 31, 2018
• Study Completion: July 31, 2018
• Last Updated: January 28, 2019

Record last verified: 2019-01

Locations

ME (1)