Ultraviolet and UV-Visible Light Photoprotection for the Treatment of Melasma

NCT01695356 | Completed Phase 4

• 1 other identifier: VISUV-melasma
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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 a Broad spectrum UV sunscreen. The experimental group, 4% topical hydroquinone and a Broad spectrum UV-visible light sunscreen. Visible light has melanotic properties and avoiding it can be part of the treatment for melasma patients. The estimated number of subjects to be recruited and randomized for the study is at least 25 per group. The purpose of this study is determine if there is a difference in the improvement between these two sunscreens types. 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.

Conditions

Melasma

Keywords

Melasma; sunscreens; visible light; ultraviolet light

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 value is pure white, 100 value is total black.

  12 weeks

Secondary Outcomes (3)

• MASI (Melasma Area Severity Index)

  12 weeks

• Melanin content by histologic quantification.

  12 weeks

• Global Physician Assessment

  12 weeks

Study Arms (2)

290-400 nm sunscreen

ACTIVE COMPARATOR

Sunscreen containing Mexoryl SX, Mexoryl XL, Titanium Dioxide, Octocrylene, Tinosorb S, Avobenzone, and Ethylhexyl triazone. Fluid vehicle administered daily, from 8AM to 5PM every 3 hr, for 12 weeks.

Drug: 290-400 nm sunscreen

290-800 nm sunscreen

EXPERIMENTAL

Sunscreen containing Benzophenone-3, Octinoxate, Octocrylene, Titanium Dioxide, Zinc Oxide, and iron oxide. Fluid vehicle administered daily, from 8AM to 5PM every 3 hr, for 12 weeks.

Drug: 290-800 nm sunscreen

Interventions

290-400 nm sunscreen DRUG

A broad UV spectrum sunscreen will be applied every 3 hours for 12 weeks. The affected surface will be covered with a 2 mg/cm\^2 layer of the product as indicated on the affected areas of the face.

Also known as: Octocrylene, Titanium dioxide, Butyl methoxydibenzoylmethane, Bis-ethylhexyloxyphenol methoxyphenyl triazine, Drometrizole trisiloxane, Ethylhexyl triazone, Terephthalylidene dicamphor sulfonic acid

290-400 nm sunscreen

290-800 nm sunscreen DRUG

A UV-visible light spectrum sunscreen will be applied every 3 hours for 12 weeks. The affected surface will be covered with a 2 mg/cm\^2 layer of the product as indicated on the affected areas of the face.

Also known as: Benzophenone-3, Octinoxate, Octocrylene, Titanium Dioxide, Zinc Oxide, Iron oxide

290-800 nm sunscreen

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Signed informed consent
• Women over 25 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 sunscreens
• 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

Sponsors & Collaborators

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

Study Sites (1)

Dermatology Department. 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

MeSH Terms

Conditions

Melanosis

Interventions

Sunscreening Agents; octocrylene; titanium dioxide; Shade UVAGuard; bis-ethylhexyloxyphenol methoxyphenyl triazine; drometrizole trisiloxane; octyl triazone; terephthalylidene dicamphor sulfonic acid; oxybenzone; octylmethoxycinnamate; Zinc Oxide; ferric oxide

Condition Hierarchy (Ancestors)

Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Radiation-Protective Agents; Protective Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Dermatologic Agents; Therapeutic Uses; Cosmetics; Specialty Uses of Chemicals; Oxides; Oxygen Compounds; Inorganic Chemicals; Zinc Compounds

Study Officials

• Diana Hernandez-Blanco, MD

  Hospital Central "Dr. Ignacio Morones Prieto"

  PRINCIPAL INVESTIGATOR

• 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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dermatology assistant professor

Study Record Dates

• First Submitted: September 25, 2012
• First Posted: September 28, 2012
• Study Start: September 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: November 1, 2013
• Last Updated: December 2, 2014

Record last verified: 2014-12

Locations

ME (1)