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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Hospital Central "Dr. Ignacio Morones Prieto"
Information provided by (Responsible Party):
Juan Pablo Castanedo-Cazares, Universidad Autonoma de San Luis Potosí
ClinicalTrials.gov Identifier:
NCT01695356
First received: September 25, 2012
Last updated: August 8, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Melasma
Drug: 290-400 nm sunscreen
Drug: 290-800 nm sunscreen
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double Blind Randomized Study Comparing the Ultraviolet (UV) Photoprotection With UV Plus Visible Light Photoprotection in the Treatment of Melasma.

Resource links provided by NLM:


Further study details as provided by Universidad Autonoma de San Luis Potosí:

Primary Outcome Measures:
  • Depigmentation of melasma lesions by Colorimetry [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • MASI (Melasma Area Severity Index) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    It is a clinical instrument of melasma measurement. 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).

  • Melanin content by histologic quantification. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.

  • Global Physician Assessment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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%).


Estimated Enrollment: 50
Study Start Date: September 2012
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 290-400 nm sunscreen

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
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.
Other Names:
  • Octocrylene
  • Titanium dioxide
  • Butyl methoxydibenzoylmethane
  • Bis-ethylhexyloxyphenol methoxyphenyl triazine
  • Drometrizole trisiloxane
  • Ethylhexyl triazone
  • Terephthalylidene dicamphor sulfonic acid
Experimental: 290-800 nm sunscreen

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
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.
Other Names:
  • Benzophenone-3
  • Octinoxate
  • Octocrylene
  • Titanium Dioxide
  • Zinc Oxide
  • Iron oxide

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 sunscreens and depigmenting compounds such as hydroquinone, are still the gold standard in this condition.

Visible light has pigmenting properties that could be interfering with the treatment in melasma patients. So, the primary objective of this study is to compare the depigmenting adjuvant effect of using a UV-visible blocking sunscreen against a UV sunscreen.

Patients who are included in the study will be randomly assigned to receive one of the sunscreen type, which should use for 12 weeks. The sun blocking agents should be applied in the affected regions every 3 hours from 8AM to 5PM. 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.

  Eligibility

Ages Eligible for Study:   25 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed informed consent
  • Women over 25 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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01695356

Locations
Mexico
Dermatology Department. Hospital Central "Dr. Ignacio Morones Prieto"
San Luis Potosi, Mexico, 78210
Sponsors and Collaborators
Universidad Autonoma de San Luis Potosí
Hospital Central "Dr. Ignacio Morones Prieto"
Investigators
Principal Investigator: Diana Hernandez-Blanco, MD Hospital Central "Dr. Ignacio Morones Prieto"
Study Director: Juan P Castanedo-Cazares, MD Hospital Central "Dr. Ignacio Morones Prieto"
Study Chair: Bertha Torres-Alvarez, MD Hospital Central "Dr. Ignacio Morones Prieto"
  More Information

Publications:
Responsible Party: Juan Pablo Castanedo-Cazares, Dermatology assistant professor, Universidad Autonoma de San Luis Potosí
ClinicalTrials.gov Identifier: NCT01695356     History of Changes
Other Study ID Numbers: VISUV-melasma
Study First Received: September 25, 2012
Last Updated: August 8, 2013
Health Authority: Mexico: Ministry of Health

Keywords provided by Universidad Autonoma de San Luis Potosí:
Melasma
sunscreens
visible light
ultraviolet light

Additional relevant MeSH terms:
Benzophenone
Sunscreening Agents
Terephthalylidene dicamphor sulfonic acid
Titanium dioxide
Dermatologic Agents
Pharmacologic Actions
Photosensitizing Agents
Physiological Effects of Drugs
Protective Agents
Radiation-Protective Agents
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014