Evaluation of an Herbal-Based De-Pigmenting System

NCT ID: NCT02138539

Last Updated: 2015-11-18

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

PHASE4

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2014-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Melasma Hyperpigmentation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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4% Hydroquinone

4% hydroquinone applied to one side of the face.

Group Type ACTIVE_COMPARATOR

Hydroquinone

Intervention Type DRUG

Hydroquinone 4% is applied twice a day to either the left or right side of the face for a duration of 4 months.

Herbal depigmenting agent

Herbal depigmenting agent applied on the other side of the face.

Group Type EXPERIMENTAL

Herbal depigmenting agent (Epionce)

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Hydroquinone

Hydroquinone 4% is applied twice a day to either the left or right side of the face for a duration of 4 months.

Intervention Type DRUG

Other Intervention Names

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Epionce

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Episciences, Inc.

INDUSTRY

Sponsor Role collaborator

Sadick Research Group

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Neil S Sadick, MD

Role: PRINCIPAL_INVESTIGATOR

Sadick Research Group

Locations

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Sadick Research Group

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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SRG-EPI-1

Identifier Type: -

Identifier Source: org_study_id