Evaluation of an Herbal-Based De-Pigmenting System

Sadick Research Group

Status and phase

Completed

Phase 4

Conditions

Hyperpigmentation

Melasma

Treatments

Other: Herbal depigmenting agent (Epionce)

Drug: Hydroquinone

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02138539

SRG-EPI-1

Details and patient eligibility

About

The purpose of this study is to evaluate the effectiveness and tolerability of an herbal de-pigmenting regimen applied to one side of the face compared with hydroquinone applied to the other side of the face in treating mottled hyperpigmentation and melasma.

Full description

This clinical study is being conducted in order to evaluate the effectiveness and tolerability of a de-pigmenting regimen when used by subjects with mild to severe mottled hyperpigmentation and melasma. Efficacy will be assessed using visual grading, device measurements and digital photography. Tolerance and safety will be evaluated by grading for objective and subjective signs of irritation, and the incidence and severity of adverse events. Efficacy and tolerance of this product are compared to that of Hydroquinone, which is applied to one side of the subject's face while the herbal de-pigmenting regimen is applied to the other side of the face.

The two product pigmentation reducing herbal regimen is based on the novel concept of inhibiting all 14 major and the 3 branch steps in the melanin cascade.

Enrollment

28 patients

Sex

Female

Ages

30 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Female age 30-65
Must be in good general health
Must be willing to use sunscreen on the face daily
Must be willing to avoid tanning beds and excessive exposure to direct sunlight
Must be willing to continue using regular cosmetic regimen

Exclusion criteria

Nursing pregnant/ planning to become pregnant during the course of the study
Using a medication that increases sensitivity to sunlight including doxycycline, minocycline, tetracycline, ciprofloxin, hydrochlorothiazide, and sulfonamides.
Any known allergies/sensitivities to facial skincare products, anti-aging products, de-pigmenting products, or products containing hydroquinone
Usage of any new skincare products during the course of the study
Presence of atopic dermatitis or psoriasis on the face
Uncontrolled diabetes, hypertension, hypothyroidism, hyperthyroidism
TCA or other deep peels within 1 year or medium to light peels within 3 months prior to starting the study
Facial/laser treatment within the last 3 months
Facial cosmetic surgery within the last 12 months
Use of product, topical, or systemic medication, known to affect dyschromia, having "whitening" or anti-aging properties
Physical skin conditions such as excessive hair, scarring, tattoos that might impair evaluations of the test sites
Active hepatitis, immune deficiency, or autoimmune disease