Evaluation of an Herbal-Based De-Pigmenting System
|ClinicalTrials.gov Identifier: NCT02138539|
Recruitment Status : Completed
First Posted : May 14, 2014
Last Update Posted : November 18, 2015
|Condition or disease||Intervention/treatment||Phase|
|Melasma Hyperpigmentation||Other: Herbal depigmenting agent (Epionce) Drug: Hydroquinone||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
Active Comparator: 4% Hydroquinone
4% hydroquinone applied to one side of the face.
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
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02138539
|United States, New York|
|Sadick Research Group|
|New York, New York, United States, 10075|
|Principal Investigator:||Neil S Sadick, MD||Sadick Research Group|