Evaluation of an Herbal-Based De-Pigmenting System

A Clinical Usage Study to Evaluate the Safety and Efficacy of an Herbal-Based De-Pigmenting System

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.

Study Overview

• Status: Completed
• Conditions: Hyperpigmentation; Melasma
• Intervention / Treatment: Drug: Hydroquinone; Other: Herbal depigmenting agent (Epionce)

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10075
      • Sadick Research Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 4% Hydroquinone; 4% hydroquinone applied to one side of the face.	Drug: Hydroquinone; Hydroquinone 4% is applied twice a day to either the left or right side of the face for a duration of 4 months.
Experimental: Herbal depigmenting agent; Herbal depigmenting agent applied on the other side of the face.	Other: Herbal depigmenting agent (Epionce); A two product herbal pigmentation reducing regimen is applied twice a day to either the left or right side of the face for a duration of 4 months.; Other Names: Epionce

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Melanin Index	The melanin index of the skin will be measured at baseline and at each follow-up visit with a non-invasive device. At the end of the study, the change of the Melanin index over a period of 6 months will be calculated.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Irritation	Both objective irritation (erythema, edema, peeling, scaling/dryness) and subjective irritation (burning/stinging, itching, dry/tight feeling) will be measured at each visit via visual grading assessments and subject questionnaires.	Baseline, 1 month, 2 month, 4 month, 6 months

Collaborators and Investigators

• Sponsor: Sadick Research Group
• Collaborators: Episciences, Inc.
• Investigators: Principal Investigator: Neil S Sadick, MD, Sadick Research Group

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: February 26, 2014
• First Submitted That Met QC Criteria: May 13, 2014
• First Posted (Estimate): May 14, 2014

Study Record Updates

• Last Update Posted (Estimate): November 18, 2015
• Last Update Submitted That Met QC Criteria: November 17, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: melasma; hyperpigmentation; sun spots; dark spots
• Additional Relevant MeSH Terms: Skin Diseases; Pigmentation Disorders; Melanosis; Hyperpigmentation; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Antioxidants; Radiation-Protective Agents; Hydroquinone
• Other Study ID Numbers: SRG-EPI-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No