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| Name | Class |
|---|---|
| Episciences, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 4% Hydroquinone | Active Comparator | 4% hydroquinone applied to one side of the face. |
|
| Herbal depigmenting agent | Experimental | Herbal depigmenting agent applied on the other side of the face. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Herbal depigmenting agent (Epionce) | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Neil S Sadick, MD | Sadick Research Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sadick Research Group | New York | New York | 10075 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 12, 2016 | |
| Reset | Dec 5, 2016 | |
| Release | Apr 19, 2018 | |
| Reset | May 18, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 12, 2016 | Dec 5, 2016 | |||
| Apr 19, 2018 |
| ID | Term |
|---|---|
| D008548 | Melanosis |
| D017495 | Hyperpigmentation |
| ID | Term |
|---|---|
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C031927 | hydroquinone |
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|
| Hydroquinone | Drug | Hydroquinone 4% is applied twice a day to either the left or right side of the face for a duration of 4 months. |
|
| May 18, 2018 |