Clinical trial NCT03674203: Efficacy of Platelet-rich Plasma in Treatment of Melasma
Official title: Efficacy of Platelet-rich Plasma in Treatment of Melasma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Melasma
Keywords: Platelet-rich plasma
Lead sponsor: Instituto Mexicano del Seguro Social
Sponsor class: OTHER_GOV
First posted: 2018-09-17
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change of the severity of melasma.
timeFrame: one year
measure: Comparison of histological analysis
timeFrame: one year
measure: Type of melasma by dermatoscopy
timeFrame: one year
measure: Amount of melasma by dermatoscopy
timeFrame: one year
measure: Density of melasma by dermatoscopy
timeFrame: one year
measure: Presence or not of telangiectasias.
timeFrame: one year
Secondary outcomes:
measure: change in the quality of life: Sp-MELASQOL
timeFrame: one year
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Western Medical Center, Mexican Institute of Social Security
state: Jalisco
Study officials:
affiliation: Instituto Mexicano del Seguro Social
name: Clotilde Fuentes, pHD
role: PRINCIPAL_INVESTIGATOR
References: