Evaluation of an Herbal-Based De-Pigmenting System

Study Overview
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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.

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

Conditions
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Hyperpigmentation, Melasma

Intervention / Treatment
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* Other: Herbal depigmenting agent (Epionce)
* Drug: Hydroquinone


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 4% Hydroquinone<br>4% hydroquinone applied to one side of the face. | Drug: Hydroquinone<br>* Hydroquinone 4% is applied twice a day to either the left or right side of the face for a duration of 4 months.<br>|
| Experimental: Herbal depigmenting agent<br>Herbal depigmenting agent applied on the other side of the face. | Other: Herbal depigmenting agent (Epionce)<br>* 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.<br>* Other names: Epionce;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dark spots, hyperpigmentation, melasma, sun spots