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MelasmaPhase 4NCT01661556

Clinical Trial of Hydroquinone Versus Miconazol in Melasma

A Phase 4 study testing Miconazole and Hydroquinone in people with Melasma, run by Universidad Autonoma de San Luis Potosí at 1 site in Mexico.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Melasma is an acquired discoloration of the skin characterized by brown colour changes commonly on the face.The duration of this double-blind clinical trial will be 12 weeks. The control group will receive treatment with topical Hydroquinone (4%), and the other group topical miconazole. Read more about this study

Who is it for?
Ages 18 to 60 years, women only
Conditions the study is for
Melasma
What is being tested?
Miconazole and Hydroquinone
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteMexico
Study dates
Oct 2011to Dec 2015
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 18 to 60 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Signed informed consent
  • Mexican women over 18 years of age
  • Dermatologic diagnostic of melasma
  • Phototype III or more

Who cannot join

  • Pregnant or breastfeeding
  • Postbirth, abortion in the past 6 months
  • Having an endocrine or autoimmune disease
  • Under hormonal therapy of any kind including contraceptives or it´s use in the past 6 months
  • Currently under treatment for melasma including sunblock
  • Currently under radiation therapy, chemotherapy, immunosuppressants of any kind or phototherapy or it´s use in the past 6 months
  • Having used or are consuming photosensitizing substances, oral or topical

Trial locations and contacts

1 site in 1 country.

Amalia Reyes-Herrera, M.D. contact

52014448342795

Juan P Castanedo-Cazares, M.D. contact

52014448342795

castanju@yahoo.com

Mexico1 site, 1 recruiting

  • Dermatology Department. Hospital Central "Dr. Ignacio Morones Prieto"

    San Luis Potosí City, San Luis Potosí, 78210

    Juan Pablo Castanedo-Cazares, M.D., 52014448342795, castanju@yahoo.com

    Bertha Torres-Alvarez, M.D., 52014448342795, torresmab@yahoo.com.mx

    Recruiting

Other trials in Mexico

About this study

Official title: Double Blind Randomized Study of 2% Miconazol Versus 4% Hydroquinone in the Treatment for Melasma.

Melasma is an acquired discoloration of the skin characterized by brown colour changes commonly on the face.The duration of this double-blind clinical trial will be 12 weeks. The control group will receive treatment with topical Hydroquinone (4%), and the other group topical miconazole. Miconazol has antimelanotic properties and can be used as treatment for melasma patients. The estimated number of subjects to be recruited and randomized for the study is at least 30. The purpose of this study is determine if there is a difference in the effectiveness of these two agents. Melasma Area and Severity Index (MASI) score will be assessed at the beginning of the study and at weeks 4, 8, and 12. Photographs, colorimetry and histological assessment will be also evaluated. Occurrence of adverse effects will also be recorded.

Read the detailed description

Melasma is a common acquired hypermelanosis in dark skin populations, usually characterized by symmetrical, irregular macules occurring in photo-exposed areas such as face. Treatment with depigmenting compounds such as hydroquinone, are still the gold standard in this condition. Miconazol has depigmented properties that could be used as part of the treatment in melasma patients. This effect is exerted by inhibiting the tyrosinase enzyme. So, the primary objective of this study is to compare the depigmenting activity of miconazole against hydroquinone.

Patients who are included in the study will be randomly assigned to receive one of the treatments, which should use for 12 weeks. The medications should be applied in the affected regions twice a day.

The evaluation of clinical improvement will be done in a blinded modality by means of the MASI score, the Global Physician Assessment, as well as colorimetry and histological melanin content. Evaluations will be held on visits at 4, 8 and 12 weeks. Skin biopsy will be taken at onset and at 12 weeks.

At the end of the study, data will be compared concerning the former parameters. All side effects will be recorded and analysed.

Conditions
Melasma
Being tested
Miconazole, Hydroquinone
Keywords
Melasma, miconazole, hydroquinone
Medical subject headings
Melanosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MiconazoleDrug

    Also called Canesten, Monistat, Micatin

    Miconazole 2% cream will be applied twice a day for 9 weeks. The affected surface will be washed and dried before application with a thin layer of the emulsion as indicated on the affected areas of the face.

  • HydroquinoneDrug

    Also called Eldoquin, Melanex

    Hydroquinone 4% cream (Topical use), will be applied twice a day for 9 weeks. The affected surface will be washed and dried before application with a thin layer of the emulsion on affected areas of the face.

Study groups in NCT01661556
Study groupRoleWhat they receive
MiconazoleExperimentalOTC topical prescription used for fungal treatment that can be useful to the treatment of melasma due to its depigmenting properties.
Receives: Drug: Miconazole
HydroquinoneActive comparatorHydroquinone 4% cream (Topical use) a depigmenting agent used as reference will be used as control. It will be applied twice a day for 9 weeks.
Receives: Drug: Hydroquinone
PlaceboPlacebo comparatorMoisturizer cream without pharmacological effects will be used as a control.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Depigmentation of melasma lesions by Colorimetry

    Quantification of the colour change in the melasma lesions by means of the L axis of the CIE system. 0 is pure white, 100 y total dark.

    Measured: 12 weeks

Secondary outcomes (3)

  1. Global Physician Assessment

    Clinical improvement is assessed by means of digital photographic registration (frontal, right, and left views). An independent observer clinically graded the global improvement as poor (0-25%), mild (26-50%), good (51-75%), and excellent (>75%).

    Measured: 12 weeks

  2. MASI (Melasma Area Severity Index)

    The total score would range from 0-24, involving the forehead (30%), right malar (30%), left malar (30%) and chin (10%), and using area of involvement (0=absent, 1=<10%, 2=10%-29%, 3=30%-49%, 4=50%-69%, 5=70%-89% and 6=90%-100%) and darkness (0=absent, 1=slight, 2=mild, 3=marked and 4=severe). Computation would be as follows: 0.3 A(f) D(f) + 0.3 A(lm) D(lm) + 0.3 A(rm) D(rm) + 0.1 A(c) D(c).

    Measured: 12 weeks

  3. Melanin content by Fontana Masson stain

    The Fontana-Masson Stain is specific for melanin, this histochemical reaction reveals accumulations of black material wherever melanin is located. A skin biopsy of lesions will be taken initially and at the end of study. The melanin content will be quantified by a software image analysis of the slides.

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Aug 2012 (estimated)
  2. Study startOct 2011
  3. Primary completionFeb 2015 (estimated)
  4. Study completionDec 2015 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01661556
Sponsor's protocol ID
MICHQ
Status last verified
Dec 2014
First submitted
7 Aug 2012
Last updated
2 Dec 2014
Results posted
No
Data monitoring committee
No

Publications

  • Navarrete-Solis J, Castanedo-Cazares JP, Torres-Alvarez B, Oros-Ovalle C, Fuentes-Ahumada C, Gonzalez FJ, Martinez-Ramirez JD, Moncada B. A Double-Blind, Randomized Clinical Trial of Niacinamide 4% versus Hydroquinone 4% in the Treatment of Melasma. Dermatol Res Pract. 2011;2011:379173. doi: 10.1155/2011/379173. Epub 2011 Jul 21.

    PubMed 21822427

  • Torres-Alvarez B, Mesa-Garza IG, Castanedo-Cazares JP, Fuentes-Ahumada C, Oros-Ovalle C, Navarrete-Solis J, Moncada B. Histochemical and immunohistochemical study in melasma: evidence of damage in the basal membrane. Am J Dermatopathol. 2011 May;33(3):291-5. doi: 10.1097/DAD.0b013e3181ef2d45.

    PubMed 21317614

  • Moncada B, Sahagun-Sanchez LK, Torres-Alvarez B, Castanedo-Cazares JP, Martinez-Ramirez JD, Gonzalez FJ. Molecular structure and concentration of melanin in the stratum corneum of patients with melasma. Photodermatol Photoimmunol Photomed. 2009 Jun;25(3):159-60. doi: 10.1111/j.1600-0781.2009.00425.x.

    PubMed 19438997

  • Hernandez-Barrera R, Torres-Alvarez B, Castanedo-Cazares JP, Oros-Ovalle C, Moncada B. Solar elastosis and presence of mast cells as key features in the pathogenesis of melasma. Clin Exp Dermatol. 2008 May;33(3):305-8. doi: 10.1111/j.1365-2230.2008.02724.x.

    PubMed 18419607

  • Espinal-Perez LE, Moncada B, Castanedo-Cazares JP. A double-blind randomized trial of 5% ascorbic acid vs. 4% hydroquinone in melasma. Int J Dermatol. 2004 Aug;43(8):604-7. doi: 10.1111/j.1365-4632.2004.02134.x.

    PubMed 15304189

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Miconazole and Hydroquinone in people with Melasma, run by Universidad Autonoma de San Luis Potosí at 1 site in Mexico.

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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 2 Dec 2014. 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 Mexico. 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 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Amalia Reyes-Herrera, M.D. (52014448342795), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Depigmentation of melasma lesions by Colorimetry (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01661556, which also lists 5 linked publications.

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 2 Dec 2014.

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