Clinical trial NCT02138539: Evaluation of an Herbal-Based De-Pigmenting System
Official title: A Clinical Usage Study to Evaluate the Safety and Efficacy of an Herbal-Based De-Pigmenting System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Melasma
Hyperpigmentation
Keywords: hyperpigmentation
melasma
sun spots
dark spots
Lead sponsor: Sadick Research Group
Sponsor class: OTHER
Collaborators: name: Episciences, Inc.
First posted: 2014-05-14
Enrollment: 28
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility 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

Primary outcomes:
measure: Melanin Index
timeFrame: 6 months
Secondary outcomes:
measure: Irritation
timeFrame: Baseline, 1 month, 2 month, 4 month, 6 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Sadick Research Group
state: New York
Study officials:
affiliation: Sadick Research Group
name: Neil S Sadick, MD
role: PRINCIPAL_INVESTIGATOR
References: