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Evaluation of an Herbal-Based De-Pigmenting System

Primary Purpose

Melasma, Hyperpigmentation

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Herbal depigmenting agent (Epionce)

Hydroquinone

About this trial

This is an interventional treatment trial for Melasma focused on measuring hyperpigmentation, melasma, sun spots, dark spots

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)FemaleAccepts 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

Sites / Locations

Sadick Research Group

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

4% Hydroquinone

Herbal depigmenting agent

Arm Description

4% hydroquinone applied to one side of the face.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT02138539

First Posted

February 26, 2014

Last Updated

November 17, 2015

Sponsor

Sadick Research Group

Collaborators

Episciences, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02138539

Brief Title

Evaluation of an Herbal-Based De-Pigmenting System

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2015

Overall Recruitment Status

Completed

Study Start Date

October 2013 (undefined)

Primary Completion Date

October 2014 (Actual)

Study Completion Date

October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sadick Research Group

Collaborators

Episciences, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Melasma, Hyperpigmentation

Keywords

hyperpigmentation, melasma, sun spots, dark spots

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Non-Randomized

Enrollment

28 (Actual)

8. Arms, Groups, and Interventions

Arm Title

4% Hydroquinone

Arm Type

Active Comparator

Arm Description

4% hydroquinone applied to one side of the face.

Arm Title

Herbal depigmenting agent

Arm Type

Experimental

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Herbal depigmenting agent (Epionce)

Other Intervention Name(s)

Epionce

Intervention Description

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

Drug

Intervention Name(s)

Hydroquinone

Intervention Description

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

Primary Outcome Measure Information:

Title

Melanin Index

Description

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Irritation

Description

Time Frame

Baseline, 1 month, 2 month, 4 month, 6 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Neil S Sadick, MD

Organizational Affiliation

Sadick Research Group

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sadick Research Group

City

New York

State/Province

New York

ZIP/Postal Code

10075

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Evaluation of an Herbal-Based De-Pigmenting System

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