Ultraviolet and UV-Visible Light Photoprotection for the Treatment of Melasma
Condition: Melasma
MeSH terms: Melanosis
Study type: Interventional
Phase: Phase 4

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.
    

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.
    

Intervention name(s): 290-400 nm sunscreen; 290-800 nm sunscreen
Intervention type(s): Drug; Drug
Intervention description(s): 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.; 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 intervention name(s): Octocrylene; Titanium dioxide; Butyl methoxydibenzoylmethane; Bis-ethylhexyloxyphenol methoxyphenyl triazine; Drometrizole trisiloxane; Ethylhexyl triazone; Terephthalylidene dicamphor sulfonic acid; Benzophenone-3; Octinoxate; Octocrylene; Titanium Dioxide; Zinc Oxide; Iron oxide
Intervention MeSH terms: Sunscreening Agents; Zinc Oxide; Titanium dioxide; Avobenzone; Terephthalylidene dicamphor sulfonic acid; Benzophenone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Melasma; sunscreens; visible light; ultraviolet light