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Clinical Trial of Hydroquinone Versus Miconazol in Melasma

NCT ID: NCT01661556

Last Updated: 2014-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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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

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Melasma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Miconazole

OTC topical prescription used for fungal treatment that can be useful to the treatment of melasma due to its depigmenting properties.

Group Type EXPERIMENTAL

Miconazole

Intervention Type DRUG

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.

Hydroquinone

Hydroquinone 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.

Group Type ACTIVE_COMPARATOR

Hydroquinone

Intervention Type DRUG

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.

Placebo

Moisturizer cream without pharmacological effects will be used as a control.

Group Type PLACEBO_COMPARATOR

No interventions assigned to this group

Interventions

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Miconazole

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.

Intervention Type DRUG

Hydroquinone

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.

Intervention Type DRUG

Other Intervention Names

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Canesten Monistat Micatin Eldoquin Melanex

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hospital Central "Dr. Ignacio Morones Prieto"

OTHER

Sponsor Role collaborator

Universidad Autonoma de San Luis Potosí

OTHER

Sponsor Role lead

Responsible Party

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Juan Pablo Castanedo-Cazares

Clinical Professor. Dermatology department.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Juan P Castanedo-Cazares, M.D.

Role: STUDY_DIRECTOR

Hospital Central "Dr. Ignacio Morones Prieto". UASLP

Amalia Reyes-Herrera, M.D.

Role: PRINCIPAL_INVESTIGATOR

Hospital Central "Dr. Ignacio Morones Prieto". UASLP

Bertha Torres-Alvarez, M.D.

Role: STUDY_CHAIR

Hospital Central "Dr. Ignacio Morones Prieto". UASLP

Locations

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

San Luis Potosí City, San Luis Potosí, Mexico

Site Status RECRUITING

Countries

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Mexico

Central Contacts

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Amalia Reyes-Herrera, M.D.

Role: CONTACT

52014448342795

Juan P Castanedo-Cazares, M.D.

Role: CONTACT

[email protected]
52014448342795

Facility Contacts

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Juan Pablo Castanedo-Cazares, M.D.

Role: primary

[email protected]
52014448342795

Bertha Torres-Alvarez, M.D.

Role: backup

[email protected]
52014448342795

References

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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.

Reference Type BACKGROUND
PMID: 21822427 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21317614 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19438997 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18419607 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15304189 (View on PubMed)

Other Identifiers

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MICHQ

Identifier Type: -

Identifier Source: org_study_id