MelasmaPhase 4NCT02138539
Evaluation of an Herbal-Based De-Pigmenting System
A Phase 4 study testing Herbal depigmenting agent (Epionce) and Hydroquinone in people with Melasma and Hyperpigmentation, run by Sadick Research Group at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Melasma, Hyperpigmentation
- What is being tested?
- Herbal depigmenting agent (Epionce) and Hydroquinone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Oct 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Usage Study to Evaluate the Safety and Efficacy of an Herbal-Based De-Pigmenting System
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.
Read the 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.
- Conditions
- Melasma, Hyperpigmentation
- Being tested
- Herbal depigmenting agent (Epionce), Hydroquinone
- Keywords
- hyperpigmentation, melasma, sun spots, dark spots
- Medical subject headings
- Melanosis, Hyperpigmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Herbal depigmenting agent (Epionce)Other
Also called 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.
HydroquinoneDrug
Hydroquinone 4% is applied twice a day to either the left or right side of the face for a duration of 4 months.
| Study group | Role | What they receive |
|---|---|---|
| 4% Hydroquinone | Active comparator | 4% hydroquinone applied to one side of the face. Receives: Drug: Hydroquinone |
| Herbal depigmenting agent | Experimental | Herbal depigmenting agent applied on the other side of the face. Receives: Other: Herbal depigmenting agent (Epionce) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
Irritation
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.
Measured: Baseline, 1 month, 2 month, 4 month, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2014 (estimated)
- Study startOct 2013
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelasmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sadick Research Group
- Sponsor type
- University, hospital or other
- Collaborators
- Episciences, Inc.
- Responsible party
- Sponsor
- Investigators
- Neil S Sadick, MD, Principal investigator, Sadick Research Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02138539
- Sponsor's protocol ID
- SRG-EPI-1
- Status last verified
- Nov 2015
- First submitted
- 26 Feb 2014
- Last updated
- 18 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Usage Study to Evaluate the Safety and Efficacy of an Herbal-Based De-Pigmenting System
- ClinicalTrials.gov ID
- NCT02138539
- Acronym / sponsor ID
- SRG-EPI-1
- Conditions
- Melasma, Hyperpigmentation
- Keywords
- hyperpigmentation, melasma, sun spots, dark spots
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Sadick Research GroupUniversity, hospital or other
- Collaborators
- Episciences, Inc.
- Study start
- Oct 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 14 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 4% Hydroquinone | Active comparator | Drug: Hydroquinone4% hydroquinone applied to one side of the face. |
| Herbal depigmenting agent | Experimental | Other: Herbal depigmenting agent (Epionce)Herbal depigmenting agent applied on the other side of the face. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Herbal depigmenting agent (Epionce)Also: EpionceA 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 | Herbal depigmenting agent |
| HydroquinoneHydroquinone 4% is applied twice a day to either the left or right side of the face for a duration of 4 months. | Drug | 4% Hydroquinone |
Primary outcome
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.
1 secondary outcome
Irritation
Time frame: Baseline, 1 month, 2 month, 4 month, 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neil S Sadick, MD principal investigator
Sadick Research Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Herbal depigmenting agent (Epionce) and Hydroquinone in people with Melasma and Hyperpigmentation, run by Sadick Research Group at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Melanin Index (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2015.