Evaluation of an Herbal-Based De-Pigmenting System
Information source: Sadick Research Group
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Melasma; Hyperpigmentation
Intervention: Herbal depigmenting agent (Epionce) (Other); Hydroquinone (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Sadick Research Group Official(s) and/or principal investigator(s): Neil S Sadick, MD, Principal Investigator, Affiliation: Sadick Research Group
Overall contact: Aria Shafai, BA, Phone: 917-768-7276, Email: SRG@sadickdermatology.com
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.
Clinical Details
Official title: A Clinical Usage Study to Evaluate the Safety and Efficacy of an Herbal-Based De-Pigmenting System
Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Melanin Index
Secondary outcome: Irritation
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.
Eligibility
Minimum age: 30 Years.
Maximum age: 65 Years.
Gender(s): Female.
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
Locations and Contacts
Aria Shafai, BA, Phone: 917-768-7276, Email: SRG@sadickdermatology.com
Sadick Research Group, New York, New York 10075, United States; Recruiting Aria Shafai, BA, Phone: 917-768-7276, Email: SRG@sadickdermatology.com Andrew Dorizas, MD, Phone: 917-768-7276, Email: SRG@sadickdermatology.com Nils Krueger, PhD, Sub-Investigator Neil S Sadick, MD, Principal Investigator
Additional Information
Starting date: October 2013
Last updated: May 13, 2014
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