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

Universidad Autonoma de San Luis Potosí

Status and phase: Completed; Phase 4

Conditions: Melasma

Treatments: Drug: 290-400 nm sunscreen; Drug: 290-800 nm sunscreen

Study type: Interventional

Funder types: Other

Identifiers

NCT01695356

VISUV-melasma

Details and patient eligibility

About

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.

Full 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.

Enrollment: 68 patients

Sex: Female

Ages: 25 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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68 participants in 2 patient groups

290-400 nm sunscreen

Active Comparator group

Description:

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.

Treatment:

Drug: 290-400 nm sunscreen

290-800 nm sunscreen

Experimental group

Description:

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.

Treatment:

Drug: 290-800 nm sunscreen