Oral Polypodium Leucotomos for Melasma

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StatusDovršeno

Sponzori

University of Miami

KLINIČKO ISPITIVANJE: NCT01162850

BioSeek: NCT01162850

Ključne riječi

Sažetak

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.

Opis

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.

Datumi

Posljednja provjera:	06/30/2008
Prvo podneseno:	07/13/2010
Predviđena prijava poslana:	07/13/2010
Prvo objavljeno:	07/14/2010
Posljednje ažuriranje poslano:	08/03/2011
Posljednje ažuriranje objavljeno:	08/04/2011
Stvarni datum početka studija:	04/30/2008
Procijenjeni datum primarnog završetka:	05/31/2009
Procijenjeni datum završetka studije:	05/31/2009

Stanje ili bolest

Melasma

Intervencija / liječenje

Dietary Supplement: Polypodium Leucotomos

Dietary Supplement: Placebo

Faza

Grupe ruku

Ruka	Intervencija / liječenje
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

Kriterij prihvatljivosti

Dobni uvjeti za studiranje	18 Years Do 18 Years
Spolovi koji ispunjavaju uvjete za studij	Female
Prihvaća zdrave volontere	Da
Kriteriji	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.

Ishod

Primarne mjere ishoda

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.

Sekundarne mjere ishoda

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.

Oral Polypodium Leucotomos for Melasma

Ključne riječi

melasma

rak

dermatitis

melanosis

vitiligo

psorijaza

polypodium