NCT01661556

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2011

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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, 2011

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 7, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 9, 2012

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

December 2, 2014

Status Verified

December 1, 2014

Enrollment Period

3.3 years

First QC Date

August 7, 2012

Last Update Submit

December 1, 2014

Conditions

Melasma

Keywords

Melasma, miconazole, hydroquinone

Outcome Measures

Primary Outcomes (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.

    12 weeks

Secondary Outcomes (3)

  • Global Physician Assessment

    12 weeks

  • MASI (Melasma Area Severity Index)

    12 weeks

  • Melanin content by Fontana Masson stain

    12 weeks

Study Arms (3)

Miconazole

EXPERIMENTAL

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

Drug: Miconazole

Hydroquinone

ACTIVE COMPARATOR

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.

Drug: Hydroquinone

Placebo

PLACEBO COMPARATOR

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

Interventions

MiconazoleDRUG

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.

Also known as: Canesten, Monistat, Micatin
Miconazole
HydroquinoneDRUG

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.

Also known as: Eldoquin, Melanex
Hydroquinone

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

San Luis Potosí City, San Luis Potosí, 78210, Mexico

RECRUITING

Related Publications (5)

  • 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.

    PMID: 21822427BACKGROUND

  • 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.

    PMID: 21317614BACKGROUND

  • 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.

    PMID: 19438997BACKGROUND

  • 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.

    PMID: 18419607BACKGROUND

  • 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.

    PMID: 15304189BACKGROUND

MeSH Terms

Conditions

Melanosis

Interventions

MiconazoleClotrimazolehydroquinone

Condition Hierarchy (Ancestors)

HyperpigmentationPigmentation DisordersSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Juan P Castanedo-Cazares, M.D.

    Hospital Central "Dr. Ignacio Morones Prieto". UASLP

    STUDY DIRECTOR

  • Amalia Reyes-Herrera, M.D.

    Hospital Central "Dr. Ignacio Morones Prieto". UASLP

    PRINCIPAL INVESTIGATOR

  • Bertha Torres-Alvarez, M.D.

    Hospital Central "Dr. Ignacio Morones Prieto". UASLP

    STUDY CHAIR

Central Study Contacts

Amalia Reyes-Herrera, M.D.

CONTACT

52014448342795

Juan P Castanedo-Cazares, M.D.

CONTACT

52014448342795castanju@yahoo.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor. Dermatology department.

Study Record Dates

First Submitted

August 7, 2012

First Posted

August 9, 2012

Study Start

October 1, 2011

Primary Completion

February 1, 2015

Study Completion

December 1, 2015

Last Updated

December 2, 2014

Record last verified: 2014-12

Locations

ME(1)