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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

Page last updated: August 23, 2015

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