MelasmaNCT01162850
Oral Polypodium Leucotomos for Melasma
A study testing Polypodium Leucotomos in people with Melasma, run by University of Miami at 1 site in United States.
Trial summary
Primary Objective: To determine whether there is improvement in the melasma of participants taking oral Polypodium Leucotomos Secondary Objective: To determine whether oral Polypodium Leucotomos is well tolerated in study subjects with melasma. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Melasma
- What is being tested?
- Polypodium Leucotomos
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Jun 2009
- 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 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy female subjects 18-50 years of age.
- Female subjects with epidermal melasma.
- Female subjects of child-bearing potential must have been willing to use an acceptable form of birth control for the duration of the study.
- Subjects with Fitzpatrick skin types II, III, \& IV
- Subjects enrolled in this trial had a 2 week washout period if on prior treatment for melasma.
Who cannot join
- Pregnant or lactating
- Dermal Melasma
- Hormonal therapies less than or equal too 4 weeks prior to study
- Use of photosensitizing medications
- Simultaneous use of any form of treatment for melasma
- Subjects who were concurrently receiving light therapies
- Subjects who were unwilling to limit the amount of sun exposure
- Simultaneous ( or past 30 day) participation in a clinical research study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Miami Cosmetic Center
Miami, Florida, 33140
About this study
Official title: A Randomized Double-Blind Placebo Controlled Study Evaluating the Effectiveness and Tolerability of Oral Polypodium Leucotomos in Patients With Melasma
Primary Objective: To determine whether there is improvement in the melasma of participants taking oral Polypodium Leucotomos Secondary Objective: To determine whether oral Polypodium Leucotomos is well tolerated in study subjects with melasma.
To determine whether treatment with Polypodium Leucotomos improves the health-related quality of life.
Read the detailed description
Polypodium Leucotomos is a fern, also known as Calaguala used by the natives of northern Honduras as a treatment against malignant tumors Used in Spain and Central America for the treatment of psoriasis, atopic dermatitis and repigmentation of vitiligo.
Oral Polypodium Leucotomos is safe and effective in patients with melasma.
- Conditions
- Melasma
- Being tested
- Polypodium Leucotomos, Placebo
- Keywords
- Melasma
- Medical subject headings
- Melanosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polypodium LeucotomosDietary supplement
Oral capsule at 240 mg taken twice a day for 12 weeks
PlaceboDietary supplement
240 mg Placebo taken orally twice daily created by company which manufactured active ingredient
| Study group | Role | What they receive |
|---|---|---|
| Polypodium Leucotomos | Active comparator | Oral Polypodium Leucotomos twice daily plus sunscreen SPF 45 for 12 weeks. Receives: Dietary Supplement: Polypodium Leucotomos |
| Placebo | Placebo comparator | Oral Placebo twice daily plus sunscreen SPF 45 for 12 weeks. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Melasma Area and Severity Index (MASI)
The following equation is used to determine the MASI score: MASI = .3A(D+H) [forhead] + .3A(D+H)[right malar] + .3A(D+H)[left malar] + .1A(D+H)[chin]; A = area, D = darkness, and H = homogeneity. Area is based on percentage of the region covered by melasma using a 1-6 scale. Darkness is determined on a 0-3 scale. Homogeneity is based on a 0-4 scale.
Measured: Day 0, Week 4, Week 8, Week 12
Secondary outcomes (3)
Patient Assessment
Subject critiqued their melasma as either getting worse, showing no improvement, mild improvement or as showing marked improvement upon using the treatment.
Measured: Week 4, Week 8, Week 12
Evaluation of Photographs
Photos were evaluated using the grading of worse, no improvement, mild improvement or marked improvement comparing week 12 to baseline.
Measured: Post-Week 12
Adverse Events
Recorded any and all adverse events that occurred even if it was unlikely that it was associated with the study product.
Measured: Week 4, Week 8, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2010 (estimated)
- Study startMay 2008
- Primary completionJun 2009
- Study completionJun 2009
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.
- 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Investigators
- Heather Woolery-Lloyd, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01162850
- Sponsor's protocol ID
- 20070050
- Status last verified
- Jul 2008
- First submitted
- 14 Jul 2010
- Last updated
- 5 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-Blind Placebo Controlled Study Evaluating the Effectiveness and Tolerability of Oral Polypodium Leucotomos in Patients With Melasma
- ClinicalTrials.gov ID
- NCT01162850
- Acronym / sponsor ID
- 20070050
- Conditions
- Melasma
- Keywords
- Melasma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 15 Jul 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.
Primary Objective: To determine whether there is improvement in the melasma of participants taking oral Polypodium Leucotomos Secondary Objective: To determine whether oral Polypodium Leucotomos is well tolerated in study subjects with melasma.
To determine whether treatment with Polypodium Leucotomos improves the health-related quality of life.
Detailed description
Polypodium Leucotomos is a fern, also known as Calaguala used by the natives of northern Honduras as a treatment against malignant tumors Used in Spain and Central America for the treatment of psoriasis, atopic dermatitis and repigmentation of vitiligo.
Oral Polypodium Leucotomos is safe and effective in patients with melasma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Polypodium Leucotomos | Active comparator | Dietary Supplement: Polypodium LeucotomosOral Polypodium Leucotomos twice daily plus sunscreen SPF 45 for 12 weeks. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboOral Placebo twice daily plus sunscreen SPF 45 for 12 weeks. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy female subjects 18-50 years of age.
- Female subjects with epidermal melasma.
- Female subjects of child-bearing potential must have been willing to use an acceptable form of birth control for the duration of the study.
- Subjects with Fitzpatrick skin types II, III, \& IV
- Subjects enrolled in this trial had a 2 week washout period if on prior treatment for melasma.
Key exclusion criteria (8 listed)
- Pregnant or lactating
- Dermal Melasma
- Hormonal therapies less than or equal too 4 weeks prior to study
- Use of photosensitizing medications
- Simultaneous use of any form of treatment for melasma
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 LeucotomosOral capsule at 240 mg taken twice a day for 12 weeks | Dietary supplement | Polypodium Leucotomos |
| Placebo240 mg Placebo taken orally twice daily created by company which manufactured active ingredient | Dietary supplement | Placebo |
Primary outcome
Melasma Area and Severity Index (MASI)
Time frame: Day 0, Week 4, Week 8, Week 12
The following equation is used to determine the MASI score: MASI = .3A(D+H) [forhead] + .3A(D+H)[right malar] + .3A(D+H)[left malar] + .1A(D+H)[chin]; A = area, D = darkness, and H = homogeneity. Area is based on percentage of the region covered by melasma using a 1-6 scale. Darkness is determined on a 0-3 scale. Homogeneity is based on a 0-4 scale.
3 secondary outcomes
Patient Assessment
Time frame: Week 4, Week 8, Week 12
Evaluation of Photographs
Time frame: Post-Week 12
Adverse Events
Time frame: Week 4, Week 8, Week 12
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 5 Aug 2011.
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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.
Heather Woolery-Lloyd, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polypodium Leucotomos in people with Melasma, run by University of Miami at 1 site in United States.
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 5 inclusion and 8 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 5 Aug 2011. 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 United States. 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. 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?
Melasma Area and Severity Index (MASI) (time frame: Day 0, Week 4, Week 8, Week 12). 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 5 Aug 2011.