Efficacy of Platelet-rich Plasma in Treatment of Melasma

NCT ID: NCT03674203

Last Updated: 2019-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-01

Study Completion Date

2018-07-31

Brief Summary

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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

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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.

Conditions

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Melasma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Application of platelet-rich plasma

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.

Group Type EXPERIMENTAL

Platelet-Rich Plasma

Intervention Type BIOLOGICAL

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

Interventions

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Platelet-Rich Plasma

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Instituto Mexicano del Seguro Social

OTHER_GOV

Sponsor Role lead

Responsible Party

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CLOTILDE FUENTES OROZCO

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Clotilde Fuentes, pHD

Role: PRINCIPAL_INVESTIGATOR

Instituto Mexicano del Seguro Social

Locations

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Western Medical Center, Mexican Institute of Social Security

Guadalajara, Jalisco, Mexico

Site Status

Countries

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Mexico

Other Identifiers

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R-2015-1301-88.

Identifier Type: -

Identifier Source: org_study_id

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