Trials / Completed
CompletedNCT02138539
Evaluation of an Herbal-Based De-Pigmenting System
A Clinical Usage Study to Evaluate the Safety and Efficacy of an Herbal-Based De-Pigmenting System
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 28 (actual)
- Sponsor
- Sadick Research Group · Academic / Other
- Sex
- Female
- Age
- 30 Years – 65 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
| 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. |
Timeline
- Start date
- 2013-10-01
- Primary completion
- 2014-10-01
- Completion
- 2014-10-01
- First posted
- 2014-05-14
- Last updated
- 2015-11-18
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02138539. Inclusion in this directory is not an endorsement.