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Oral Polypodium Leucotomos for Melasma

Watumiaji waliosajiliwa tu ndio wanaweza kutafsiri nakala
Ingia / Ingia
Kiungo kimehifadhiwa kwenye clipboard
HaliImekamilika
Wadhamini
University of Miami

Maneno muhimu

Kikemikali

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.

Maelezo

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.

Tarehe

Imethibitishwa Mwisho: 06/30/2008
Iliyowasilishwa Kwanza: 07/13/2010
Uandikishaji uliokadiriwa Uliwasilishwa: 07/13/2010
Iliyotumwa Kwanza: 07/14/2010
Sasisho la Mwisho Liliwasilishwa: 08/03/2011
Sasisho la Mwisho Lilichapishwa: 08/04/2011
Tarehe halisi ya kuanza kwa masomo: 04/30/2008
Tarehe ya Kukamilisha Msingi iliyokadiriwa: 05/31/2009
Tarehe ya Kukamilisha Utafiti: 05/31/2009

Hali au ugonjwa

Melasma

Uingiliaji / matibabu

Dietary Supplement: Polypodium Leucotomos

Dietary Supplement: Placebo

Awamu

-

Vikundi vya Arm

MkonoUingiliaji / matibabu
Active Comparator: Polypodium Leucotomos
Oral Polypodium Leucotomos twice daily plus sunscreen SPF 45 for 12 weeks.
Dietary Supplement: Polypodium Leucotomos
Oral capsule at 240 mg taken twice a day for 12 weeks
Placebo Comparator: Placebo
Oral Placebo twice daily plus sunscreen SPF 45 for 12 weeks.
Dietary Supplement: Placebo
240 mg Placebo taken orally twice daily created by company which manufactured active ingredient

Vigezo vya Kustahiki

Zama zinazostahiki Kujifunza 18 Years Kwa 18 Years
Jinsia Inastahiki KujifunzaFemale
Hupokea Wajitolea wa AfyaNdio
Vigezo

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

Matokeo

Hatua za Matokeo ya Msingi

1. Melasma Area and Severity Index (MASI) [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.

Hatua za Matokeo ya Sekondari

1. Patient Assessment [Week 4, Week 8, Week 12]

Subject critiqued their melasma as either getting worse, showing no improvement, mild improvement or as showing marked improvement upon using the treatment.

2. Evaluation of Photographs [Post-Week 12]

Photos were evaluated using the grading of worse, no improvement, mild improvement or marked improvement comparing week 12 to baseline.

3. Adverse Events [Week 4, Week 8, Week 12]

Recorded any and all adverse events that occurred even if it was unlikely that it was associated with the study product.

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