MelasmaPhase 4NCT01695356
Ultraviolet and UV-Visible Light Photoprotection for the Treatment of Melasma
A Phase 4 study testing 290-400 nm sunscreen and 290-800 nm sunscreen in people with Melasma, run by Universidad Autonoma de San Luis Potosí at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 60 years, women only
- Conditions the study is for
- Melasma
- What is being tested?
- 290-400 nm sunscreen and 290-800 nm sunscreen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteMexico
- Study dates
- Sep 2012to Nov 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Signed informed consent
- Women over 25 years of age
- Dermatologic diagnostic of melasma
- Phototype III or more
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Mexico1 site
Dermatology Department. Hospital Central "Dr. Ignacio Morones Prieto"
San Luis Potosí City, San Luis Potosí, 78210
About this study
Official title: A Double Blind Randomized Study Comparing the Ultraviolet (UV) Photoprotection With UV Plus Visible Light Photoprotection in the Treatment of Melasma.
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.
Read the 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.
- Conditions
- Melasma
- Being tested
- 290-400 nm sunscreen, 290-800 nm sunscreen
- Keywords
- Melasma, sunscreens, visible light, ultraviolet light
- Medical subject headings
- Melanosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
290-400 nm sunscreenDrug
Also called Octocrylene, Titanium dioxide, Butyl methoxydibenzoylmethane, Bis-ethylhexyloxyphenol methoxyphenyl triazine
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.
290-800 nm sunscreenDrug
Also called Benzophenone-3, Octinoxate, Octocrylene, Titanium Dioxide
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: 290-800 nm sunscreen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (3)
MASI (Melasma Area Severity Index)
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).
Measured: 12 weeks
Melanin content by histologic quantification.
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.
Measured: 12 weeks
Global Physician Assessment
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%).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionOct 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for MelasmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de San Luis Potosí
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Central "Dr. Ignacio Morones Prieto"
- Responsible party
- Principal investigator, Juan Pablo Castanedo-Cazares, Universidad Autonoma de San Luis Potosí
- Investigators
- Diana Hernandez-Blanco, MD, Principal investigator, Hospital Central "Dr. Ignacio Morones Prieto"Juan P Castanedo-Cazares, MD, Study director, Hospital Central "Dr. Ignacio Morones Prieto"Bertha Torres-Alvarez, MD, Study chair, Hospital Central "Dr. Ignacio Morones Prieto"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01695356
- Sponsor's protocol ID
- VISUV-melasma
- Status last verified
- Dec 2014
- First submitted
- 25 Sep 2012
- Last updated
- 2 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21822427Torres-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.
PubMed 21317614Moncada 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.
PubMed 19438997Hernandez-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.
PubMed 18419607Espinal-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.
PubMed 15304189
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind Randomized Study Comparing the Ultraviolet (UV) Photoprotection With UV Plus Visible Light Photoprotection in the Treatment of Melasma.
- ClinicalTrials.gov ID
- NCT01695356
- Acronym / sponsor ID
- VISUV-melasma
- Conditions
- Melasma
- Keywords
- Melasma, sunscreens, visible light, ultraviolet light
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Universidad Autonoma de San Luis PotosíUniversity, hospital or other
- Collaborators
- Hospital Central "Dr. Ignacio Morones Prieto"
- Study start
- Sep 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 28 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 290-400 nm sunscreen | Active comparator | Drug: 290-400 nm sunscreenSunscreen 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. |
| 290-800 nm sunscreen | Experimental | Drug: 290-800 nm sunscreenSunscreen 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. |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Signed informed consent
- Women over 25 years of age
- Dermatologic diagnostic of melasma
- Phototype III or more
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 290-400 nm sunscreenAlso: Octocrylene, Titanium dioxide, Butyl methoxydibenzoylmethane, Bis-ethylhexyloxyphenol methoxyphenyl triazineA 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. | Drug | 290-400 nm sunscreen |
| 290-800 nm sunscreenAlso: Benzophenone-3, Octinoxate, Octocrylene, Titanium DioxideA 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. | Drug | 290-800 nm sunscreen |
Primary outcome
Depigmentation of melasma lesions by Colorimetry
Time frame: 12 weeks
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.
3 secondary outcomes
MASI (Melasma Area Severity Index)
Time frame: 12 weeks
Melanin content by histologic quantification.
Time frame: 12 weeks
Global Physician Assessment
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2014.
- Background: PubMed 21822427Navarrete-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.
- Background: PubMed 21317614Torres-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.
- Background: PubMed 19438997Moncada 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.
- Background: PubMed 18419607Hernandez-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.
- Background: PubMed 15304189Espinal-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diana Hernandez-Blanco, MD principal investigator
Hospital Central "Dr. Ignacio Morones Prieto"
Juan P Castanedo-Cazares, MD study director
Hospital Central "Dr. Ignacio Morones Prieto"
Bertha Torres-Alvarez, MD study chair
Hospital Central "Dr. Ignacio Morones Prieto"
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 290-400 nm sunscreen and 290-800 nm sunscreen in people with Melasma, run by Universidad Autonoma de San Luis Potosí at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depigmentation of melasma lesions by Colorimetry (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01695356, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2014.