A randomized, double-blind, placebo-controlled trial of oral procyanidin with vitamins A, C, E for melasma among Filipino women.
BACKGROUND
Melasma is a common, acquired, symmetric hypermelanosis characterized by irregular brown to gray-brown macules on the cheeks, forehead, nasal bridge, cutaneous part of the upper lip, mandible, and the upper arms. Few trials have been conducted regarding the potential benefits of oral procyanidin in melasma.


OBJECTIVE
To assess the safety and efficacy of oral procyanidin + vitamins A, C, E among Filipino patients with epidermal melasma.


METHODS
A randomized, double-blind, placebo-controlled trial lasting 8 weeks, involving 60 adult female volunteers with bilateral epidermal melasma, Fitzpatrick skin types III-V, was conducted at the Section of Dermatology, Research Institute for Tropical Medicine, Department of Health, Manila, Philippines. Patients received either the test drug or placebo, twice daily with meals. Changes in pigmentation were measured using a mexameter, the melasma area and severity index (MASI), and a global evaluation by the patient and investigator. Safety evaluations were performed at each follow-up visit.


RESULTS
Fifty-six patients completed the trial. Mexameter results demonstrated a significant decrease in the degree of pigmentation in the left malar (165.85 +/- 70.909) and right malar (161.33 +/- 61.824) regions (P < 0.0001). MASI scores showed a significant improvement in the left malar (2.4862 +/- 1.67816) and right malar (1.8889 +/- 1.67110) regions (P = 0.001). Procyanidin + vitamins A, C, E proved to be safe and well tolerated, with minimal adverse events.


CONCLUSIONS
In this 8-week trial period, oral procyanidin + vitamins A, C, E proved to be safe and effective among Filipino women with epidermal melasma.
Handog
Evangeline B
EB
The Section of Dermatology, Department of Health, Research Institute for Tropical Medicine, Manila, Philippines. handogmd@pacific.net.ph
Galang
Dulce Amor Vivan F
DA
de Leon-Godinez
Maria Azirrel
MA
Chan
Gertrude P
GP
D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000975:Antioxidants / Q000008:administration & dosage* / Q000009:adverse effects; D001205:Ascorbic Acid / Q000008:administration & dosage / Q000009:adverse effects; D044946:Biflavonoids / Q000008:administration & dosage* / Q000009:adverse effects; D002392:Catechin / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008548:Melanosis / Q000188:drug therapy*; D008875:Middle Aged; D010679:Philippines; D010919:Placebos; D044945:Proanthocyanidins / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome; D014801:Vitamin A / Q000008:administration & dosage / Q000009:adverse effects; D014810:Vitamin E / Q000008:administration & dosage / Q000009:adverse effects; D014815:Vitamins / Q000008:administration & dosage* / Q000009:adverse effects; D055815:Young Adult
D000975:Antioxidants; D044946:Biflavonoids; D010919:Placebos; D044945:Proanthocyanidins; D014815:Vitamins; D014801:Vitamin A; D014810:Vitamin E; C017674:procyanidin; D002392:Catechin; D001205:Ascorbic Acid