MelasmaNCT01092884
Polypodium Leucotomos Extract for the Treatment of Melasma
A study testing Polypodium leucotomos extract in people with Melasma, run by University of Texas Southwestern Medical Center.
Trial summary
We will assess whether oral supplementation with Polypodium leucotomos, a commercially marketed fern extract, improves facial melasma in Hispanic women with moderate to severe melasma. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Melasma
- What is being tested?
- Polypodium leucotomos extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Mar 2010to Jul 2012
- Phase
- Interventional
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Hispanic female with moderate to severe facial melasma
Who cannot join
- Currently pregnant or breastfeeding
- Recent use of hydroquinone, topical retinoids, topical steroids, or mechanically abrading procedures (such as laser therapy or dermabrasion) to the face
- Frequent use of tanning parlors
About this study
Official title: Polypodium Leucotomos Extract as an Adjunct to Sunscreen for the Treatment of Melasma
We will assess whether oral supplementation with Polypodium leucotomos, a commercially marketed fern extract, improves facial melasma in Hispanic women with moderate to severe melasma. Subjects will be randomized to either Group 1, which will receive oral Polypodium leucotomos extract plus topical sunscreen, or Group 2, which will receive oral placebo plus topical sunscreen. The study will last 12 weeks, and we hypothesize that the Polypodium leucotomos group will have more improvement in their melasma compared to the placebo group.
- Conditions
- Melasma
- Being tested
- Polypodium leucotomos extract, Placebo
- Keywords
- melasma, sunscreen, polypodium leucotomos
- Medical subject headings
- Melanosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polypodium leucotomos extractDietary supplement
Also called Heliocare
240 mg capsule of Polypodium leucotomos extract will be taken orally three times daily
PlaceboOther
This placebo capsule will be taken orally three times daily
| Study group | Role | What they receive |
|---|---|---|
| Polypodium leucotomos | Active comparator | Subjects randomized to this arm will receive oral supplementation with Polypodium leucotomos extract Receives: Dietary Supplement: Polypodium leucotomos extract |
| Sugar pill | Placebo comparator | Subjects randomized to this arm will receive oral supplementation with placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mexameter score
Using rapid, non-invasive, narrow-band reflectance spectrophotometry (Mexameter), we will assess change in intensity of pigment in affected skin versus unaffected skin at 12 weeks
Measured: 12 weeks
Secondary outcomes (2)
MASI Score
We will use the standardized Melasma Area and Severity Index (MASI) score, assessed by blinded physician investigator, to assess change in severity of melasma at 12 weeks compared to baseline
Measured: 12 weeks
Melasma-Related Quality of Life
We will use a validated questionnaire tool to assess change in melasma-related quality of life at 12 weeks compared to baseline
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 posted25 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionJul 2011
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelasmaStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Industrial Farmacéutica Cantabria, S.A.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01092884
- Sponsor's protocol ID
- 092009-036
- Status last verified
- Mar 2010
- First submitted
- 23 Mar 2010
- Last updated
- 6 Sep 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polypodium Leucotomos Extract as an Adjunct to Sunscreen for the Treatment of Melasma
- ClinicalTrials.gov ID
- NCT01092884
- Acronym / sponsor ID
- 092009-036
- Conditions
- Melasma
- Keywords
- melasma, sunscreen, polypodium leucotomos
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- Industrial Farmacéutica Cantabria, S.A.
- Study start
- Mar 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 25 Mar 2010 (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.
We will assess whether oral supplementation with Polypodium leucotomos, a commercially marketed fern extract, improves facial melasma in Hispanic women with moderate to severe melasma. Subjects will be randomized to either Group 1, which will receive oral Polypodium leucotomos extract plus topical sunscreen, or Group 2, which will receive oral placebo plus topical sunscreen. The study will last 12 weeks, and we hypothesize that the Polypodium leucotomos group will have more improvement in their melasma compared to the placebo group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Polypodium leucotomos | Active comparator | Dietary Supplement: Polypodium leucotomos extractSubjects randomized to this arm will receive oral supplementation with Polypodium leucotomos extract |
| Sugar pill | Placebo comparator | Other: PlaceboSubjects randomized to this arm will receive oral supplementation with placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Hispanic female with moderate to severe facial melasma
Key exclusion criteria (3 listed)
- Currently pregnant or breastfeeding
- Recent use of hydroquinone, topical retinoids, topical steroids, or mechanically abrading procedures (such as laser therapy or dermabrasion) to the face
- Frequent use of tanning parlors
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 |
|---|---|---|
| Polypodium leucotomos extractAlso: Heliocare240 mg capsule of Polypodium leucotomos extract will be taken orally three times daily | Dietary supplement | Polypodium leucotomos |
| PlaceboThis placebo capsule will be taken orally three times daily | Other | Sugar pill |
Primary outcome
Mexameter score
Time frame: 12 weeks
Using rapid, non-invasive, narrow-band reflectance spectrophotometry (Mexameter), we will assess change in intensity of pigment in affected skin versus unaffected skin at 12 weeks
2 secondary outcomes
MASI Score
Time frame: 12 weeks
Melasma-Related Quality of Life
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 6 Sep 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Polypodium leucotomos extract in people with Melasma, run by University of Texas Southwestern Medical Center.
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 1 inclusion and 3 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 6 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Mexameter score (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Sep 2023.