Facial MelasmaPhase 3NCT02095990
Efficacy and Safety of a 4% Hydroquinone Cream for the Treatment of Melasma
A Phase 3 study testing Hydroquinone in people with Facial Melasma, run by Mesoestetic Pharma Group S.L. at 1 site in Spain.
Trial summary
To assess the ability of a new 4% Hydroquinone formulation (Melanoderm 4% Crema) to reduce melasma on the face, using a split-face randomization design, evaluating the MASI Score from baseline to week 4 and week 8, in both half-faces receiving active treatment vs. placebo. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Facial Melasma
- What is being tested?
- Hydroquinone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2014to Aug 2014
- Phase
- Phase 3
- 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 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult women aged between 18-65 years old.
- Fitzpatrick phototypes I to IV.
- Presenting moderate to severe facial melasma facial, with a basal Melasma Area and Severity Index (MASI Index) between 10 and 20.
- Women of childbearing potential must use an adequate contraceptive method to avoid pregnancy and must have a negative pregnancy test in a maximum of 72 hours before receiving the trial treatment.
- Breastfeeding women will not be included in the study.
- Having given freely and expressly her informed consent.
Who cannot join
- Those with any history of allergy or hypersensitivity to a cosmetic product, hydroquinone, or one of the ingredients of the investigational products.
- Fitzpatrick phototype V.
- Skin pigmentation diseases different to melasma.
- Evidence of active cancer disease or diagnosis of cancer in the last year.
- Those receiving any topical or oral treatment that could interfere with melasma.
- Pregnant or breastfeeding women, or those expecting to get pregnant during the study.
- Evidence or suspicion of low compliance with the study visits and procedures.
- Participation in other clinical trial simultaneously or in the previous 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of a 4% Hydroquinone Cream (Melanoderm 4%) for the Treatment of Melasma: a Randomized Controlled Split-face Study
To assess the ability of a new 4% Hydroquinone formulation (Melanoderm 4% Crema) to reduce melasma on the face, using a split-face randomization design, evaluating the MASI Score from baseline to week 4 and week 8, in both half-faces receiving active treatment vs. placebo.
To assess the tolerance of a new 4% Hydroquinone formulation (Melanoderm 4% Crema) on the face.
To assess patients' satisfaction regarding Melanoderm 4% Crema after 8 weeks.
- Conditions
- Facial Melasma
- Being tested
- Hydroquinone, Placebo
- Keywords
- Facial Melasma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydroquinoneDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Hydroquinone | Experimental | Hydroquinone 4% Cream will be applied in one side of the face while the other side of the face receives placebo.
Half of the patients will receive Hydroquinone on the right side of the face and the other half on the left side.
It will be applied daily, at night, during 8 weeks. Receives: Drug: Hydroquinone |
| Placebo | Placebo comparator | Placebo cream (vehicle of Hydroquinone 4% cream), will be applied in one side of the face, while the other side receives the active treatment.
Half of the patients will receive Hydroquinone on the right side of the face and the other half on the left side.
It will be applied daily, at night, during 8 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the ability of a new 4% Hydroquinone formulation (Melanoderm 4% Crema) to reduce melasma on the face.
Efficacy assessments will be measured by the Melasma Area and Severity Index (MASI Index) at baseline, week 4 and week 8 (end of treatment).
Measured: Baseline, week 4, week 8.
Secondary outcomes (1)
To assess the tolerance of a new 4% Hydroquinone formulation (Melanoderm 4% Crema) on the face.
Adverse events will be recorded throughout the study and 30 days after the end of treatment.
Measured: Week 4, Week 8, Follow-up period (Week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mesoestetic Pharma Group S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Susana Puig, MD, Principal investigator, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02095990
- Sponsor's protocol ID
- ECM2013
- Status last verified
- Apr 2015
- First submitted
- 21 Mar 2014
- Last updated
- 30 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of a 4% Hydroquinone Cream (Melanoderm 4%) for the Treatment of Melasma: a Randomized Controlled Split-face Study
- ClinicalTrials.gov ID
- NCT02095990
- Acronym / sponsor ID
- ECM2013
- Conditions
- Facial Melasma
- Keywords
- Facial Melasma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Mesoestetic Pharma Group S.L.Industry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 26 Mar 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.
To assess the ability of a new 4% Hydroquinone formulation (Melanoderm 4% Crema) to reduce melasma on the face, using a split-face randomization design, evaluating the MASI Score from baseline to week 4 and week 8, in both half-faces receiving active treatment vs. placebo.
To assess the tolerance of a new 4% Hydroquinone formulation (Melanoderm 4% Crema) on the face.
To assess patients' satisfaction regarding Melanoderm 4% Crema after 8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydroquinone | Experimental | Drug: HydroquinoneHydroquinone 4% Cream will be applied in one side of the face while the other side of the face receives placebo. Half of the patients will receive Hydroquinone on the right side of the face and the other half on the left side. It will be applied daily, at night, during 8 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo cream (vehicle of Hydroquinone 4% cream), will be applied in one side of the face, while the other side receives the active treatment. Half of the patients will receive Hydroquinone on the right side of the face and the other half on the left side. It will be applied daily, at night, during 8 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult women aged between 18-65 years old.
- Fitzpatrick phototypes I to IV.
- Presenting moderate to severe facial melasma facial, with a basal Melasma Area and Severity Index (MASI Index) between 10 and 20.
- Women of childbearing potential must use an adequate contraceptive method to avoid pregnancy and must have a negative pregnancy test in a maximum of 72 hours before receiving the trial treatment.
- Breastfeeding women will not be included in the study.
Key exclusion criteria (8 listed)
- Those with any history of allergy or hypersensitivity to a cosmetic product, hydroquinone, or one of the ingredients of the investigational products.
- Fitzpatrick phototype V.
- Skin pigmentation diseases different to melasma.
- Evidence of active cancer disease or diagnosis of cancer in the last year.
- Those receiving any topical or oral treatment that could interfere with melasma.
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 |
|---|---|---|
| Hydroquinone | Drug | Hydroquinone |
| Placebo | Drug | Placebo |
Primary outcome
To assess the ability of a new 4% Hydroquinone formulation (Melanoderm 4% Crema) to reduce melasma on the face.
Time frame: Baseline, week 4, week 8.
Efficacy assessments will be measured by the Melasma Area and Severity Index (MASI Index) at baseline, week 4 and week 8 (end of treatment).
1 secondary outcome
To assess the tolerance of a new 4% Hydroquinone formulation (Melanoderm 4% Crema) on the face.
Time frame: Week 4, Week 8, Follow-up period (Week 12)
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 30 Sep 2019.
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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.
Susana Puig, MD principal investigator
Hospital Clinic of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hydroquinone in people with Facial Melasma, run by Mesoestetic Pharma Group S.L. at 1 site in Spain.
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 6 inclusion and 8 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 30 Sep 2019. 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 Spain. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
To assess the ability of a new 4% Hydroquinone formulation (Melanoderm 4% Crema) to reduce melasma on the face. (time frame: Baseline, week 4, week 8.). 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 30 Sep 2019.