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Evaluation of an Herbal-Based De-Pigmenting System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02138539
Recruitment Status : Completed
First Posted : May 14, 2014
Last Update Posted : November 18, 2015
Sponsor:
Collaborator:
Episciences, Inc.
Information provided by (Responsible Party):
Sadick Research Group

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Melasma Hyperpigmentation Other: Herbal depigmenting agent (Epionce) Drug: Hydroquinone Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Clinical Usage Study to Evaluate the Safety and Efficacy of an Herbal-Based De-Pigmenting System
Study Start Date : October 2013
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

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Arms and Interventions
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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 Name: Epionce


Outcome Measures
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Primary Outcome Measures :
  1. Melanin Index [ Time Frame: 6 months ]
    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.


Secondary Outcome Measures :
  1. Irritation [ Time Frame: Baseline, 1 month, 2 month, 4 month, 6 months ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02138539


Locations
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United States, New York
Sadick Research Group
New York, New York, United States, 10075
Sponsors and Collaborators
Sadick Research Group
Episciences, Inc.
Investigators
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Principal Investigator: Neil S Sadick, MD Sadick Research Group
More Information
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Responsible Party: Sadick Research Group
ClinicalTrials.gov Identifier: NCT02138539    
Other Study ID Numbers: SRG-EPI-1
First Posted: May 14, 2014    Key Record Dates
Last Update Posted: November 18, 2015
Last Verified: November 2015
Keywords provided by Sadick Research Group:
hyperpigmentation
melasma
sun spots
dark spots
Additional relevant MeSH terms:
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Melanosis
Hyperpigmentation
Pigmentation Disorders
Skin Diseases
Hydroquinone
 Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Radiation-Protective Agents