Inflammation in Melasma: Study of Its Infiltrate and the Expression of Acute and Chronic Mediators

NCT01952379 | Completed

• 1 other identifier: mel-Infla1
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Melasma is an acquired hyperpigmentary disorder that commonly affects women from Asia and Latin-America.There is evidence of subclinical inflammation supported by diffuse spectrometry and by prominent inflammatory cells in affected areas; however this infiltrate and its inflammatory mediators remains unexplored. Chronic inflammation induces melanogenesis and angiogenesis; thus, it could be linked to its recurrent nature.Therefore, the aim of this study is to describe the inflammatory cellular infiltrate, and the expression of main inflammatory and angiogenic mediators in this condition, as well as to explore its relationship with severity of disease. Using histological, histochemistry, immunohistochemistry, and quantitative real-time PCR, we evaluated melasma lesions from 20 healthy female patients with malar melasma without specific solar exposure or photoprotection measures within the previous 3 weeks and compared them to non lesional skin.

Conditions

Melasma

Keywords

Melasma; Lymphocytes; Macrophages; Mast cells; Interleukin 17; COX-2; Inflammation

Outcome Measures

Primary Outcomes (1)

• Inflammatory cellular infiltrate

  Determine by immunohistochemistry common inflammatory cellular infiltrate in melasma lesions and non affected skin (i.e CD1, CD68, CD4, CD8).

  Single time measurement

Secondary Outcomes (2)

• Acute inflammatory mediators

  Single time measurement

• Chronic inflammatory mediators

  Single time measurement

Other Outcomes (1)

• Correlation between inflammation markers and pigmentation

  Single time measurement

Study Arms (1)

Melasma

Women affected by symmetric facial malar melasma.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women affected with malar melasma.

You may qualify if:

• Women older than 18 years under signed informed consent form.
• Symmetrical and bilateral lesions.
• Melasma with MASI scores greater than 12 points.

You may not qualify if:

• Melasma treatment or photoprotection measures within last 2 months.
• Pregnant women or nursing.
• Miscarriage or labor in the last 12 months.
• Menopause
• Coexistence of other pigmentation disorders.
• Infrared radiation exposure.
• Regular exercise or diet restriction.
• Consumption of food supplements.
• Any type of drugs consumption in the last 2 months (i.e anti-inflammatories and hormonal treatments)
• Personal history of keloid or hypertrophic scars.
• Lidocaine allergy.

Sponsors & Collaborators

• Universidad Autonoma de San Luis Potosí: lead
• Hospital Central "Dr. Ignacio Morones Prieto": collaborator

Study Sites (1)

Hospital Central Dr. Ignacio Morones Prieto

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

Location

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: 21822427 BACKGROUND

• 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: 21317614 BACKGROUND

• 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: 19438997 BACKGROUND

• 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: 18419607 BACKGROUND

• 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: 15304189 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

3 mm Skin punch biopsies

MeSH Terms

Conditions

Melanosis; Inflammation

Condition Hierarchy (Ancestors)

Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Juan P Castanedo-Cazares, MD

  Hospital Central "Dr. Ignacio Morones Prieto"

  STUDY DIRECTOR

• Bertha Torres-Alvarez, MD

  Hospital Central "Dr. Ignacio Morones Prieto"

  STUDY CHAIR

• Adriana Rodriguez-Arambula, MD

  Hospital Central "Dr. Ignacio Morones Prieto"

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dermatology department research director

Study Record Dates

• First Submitted: September 24, 2013
• First Posted: September 27, 2013
• Study Start: July 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: November 25, 2014

Record last verified: 2014-11

Locations

ME (1)