NCT02138539

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Oct 2013

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 26, 2014

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 14, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

November 18, 2015

Status Verified

November 1, 2015

Enrollment Period

1 year

First QC Date

February 26, 2014

Last Update Submit

November 17, 2015

Conditions

MelasmaHyperpigmentation

Keywords

hyperpigmentationmelasmasun spotsdark spots

Outcome Measures

Primary Outcomes (1)

  • Melanin Index

    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.

    6 months

Secondary Outcomes (1)

  • Irritation

    Baseline, 1 month, 2 month, 4 month, 6 months

Study Arms (2)

4% Hydroquinone

ACTIVE COMPARATOR

4% hydroquinone applied to one side of the face.

Drug: Hydroquinone

Herbal depigmenting agent

EXPERIMENTAL

Herbal depigmenting agent applied on the other side of the face.

Other: Herbal depigmenting agent (Epionce)

Interventions

Herbal depigmenting agent (Epionce)OTHER

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.

Also known as: Epionce
Herbal depigmenting agent
HydroquinoneDRUG

Hydroquinone 4% is applied twice a day to either the left or right side of the face for a duration of 4 months.

4% Hydroquinone

Eligibility Criteria

Age30 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sadick Research Group

New York, New York, 10075, United States

Location

MeSH Terms

Conditions

MelanosisHyperpigmentation

Interventions

hydroquinone

Condition Hierarchy (Ancestors)

Pigmentation DisordersSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Neil S Sadick, MD

    Sadick Research Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2014

First Posted

May 14, 2014

Study Start

October 1, 2013

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

November 18, 2015

Record last verified: 2015-11

Locations

US(1)