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8-MOP (Methoxsalen) - Summary


CAUTION: 8-MOP® Capsules (Methoxsalen Hard Gelatin Capsules) may not be interchanged with Oxsoralen-Ultra® Capsules (Methoxsalen Soft Gelatin Capsules) without retitration of the patient.



8-MOP (Methoxsalen, 8-Methoxypsoralen) Capsules, 10mg. Methoxsalen is a naturally occurring photoactive substance found in the seeds of the Ammi majus (Umbelliferae) plant and in the roots of Heracleum Candicans. It belongs to a group of compounds known as psoralens, or furocoumarins.

8-MOP is indicated for the follwoing:

  1. Photochemotherapy (methoxsalen with long wave UVA radiation) is indicated for the symptomatic control of severe, recalcitrant, disabling psoriasis not adequately responsive to other forms of therapy and when the diagnosis has been supported by biopsy. Photochemotherapy is intended to be administered only in conjunction with a schedule of controlled doses of long wave ultraviolet radiation.
  2. Photochemotherapy (methoxsalen with long wave ultraviolet radiation) is indicated for the repigmentation of idiopathic vitiligo.
  3. Photopheresis (methoxsalen with long wave ultraviolet radiation of white blood cells) is indicated for use with the UVAR* System in the palliative treatment of the skin manifestations of cutaneous T-cell lymphoma (CTCL) in persons who have not been responsive to other forms of treatment. While this dosage form of methoxsalen has been approved for use in combination with photopheresis, Oxsoralen Ultra® Capsules have not been approved for that use.

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Published Studies Related to 8-MOP (Methoxsalen)

Oral vs. bath PUVA using 8-methoxypsoralen for chronic palmoplantar eczema. [2009.04]
BACKGROUND: Both oral and bath PUVA with 8-methoxypsoralen (8-MOP) have been shown to be effective in the treatment of chronic palmoplantar eczema. However, most studies were retrospective and did not include longer follow-up periods. AIM: To compare the therapeutic efficacy, tolerability and duration of remission after oral vs. bath PUVA using 8-MOP in patients with chronic palmoplantar eczema... CONCLUSION: Oral PUVA is preferable for patients with hyperkeratotic eczema and bath PUVA for patients with dyshidrotic eczema.

Randomized, double-blind comparison of 1 mg/L versus 5 mg/L methoxsalen bath-PUVA therapy for chronic plaque-type psoriasis. [2006.10]
BACKGROUND: Bath-psoralen plus ultraviolet A (PUVA) radiation therapy is increasingly replacing oral PUVA because of its superior short- and long-term safety profile. Several investigations in recent years have led to a refinement of the bath-PUVA protocol; however, the optimal therapeutic concentration of methoxsalen in the bath water has as yet not been delineated. OBJECTIVES: The therapeutic efficacy and tolerability of bath-PUVA by using two different dilutions of methoxsalen (1 mg/L vs 5 mg/L or 0.0001% vs 0.0005%) were compared in 46 patients with chronic plaque-type psoriasis in a prospective, randomized, double-blind study... CONCLUSIONS: Our data indicate that in bath-PUVA treatment the use of a high (5 mg/L) methoxsalen concentration is substantially more effective in clearing chronic plaque-type psoriasis than a low (1 mg/L) concentration.

Narrowband UV-B (TL-01) phototherapy vs oral 8-methoxypsoralen psoralen-UV-A for the treatment of chronic plaque psoriasis. [2003.03]
OBJECTIVE: To compare the efficacy of narrowband UV-B (TL-01) phototherapy with oral 8-methoxypsoralen photochemotherapy (8-MOP psoralen-UV-A [PUVA]) in patients with chronic plaque psoriasis (CPP)... CONCLUSION: Narrowband UV-B phototherapy, used 3 times weekly, is as effective for the treatment of CPP as oral 8-MOP PUVA used twice weekly.

Time course of 8-methoxypsoralen concentrations in skin and plasma after topical (bath and cream) and oral administration of 8-methoxypsoralen. [2002.03]
BACKGROUND: The combination of 8-methoxypsoralen with ultraviolet A exposure (PUVA therapy) is a standard treatment for a variety of dermatoses. The following three variants have been described: oral, bath, or cream PUVA. To achieve optimal therapeutic effects, ultraviolet A irradiation should be performed at the time of maximum photosensitivity, that is, at the time of maximum 8-methoxypsoralen tissue concentrations... CONCLUSIONS: The time course of tissue concentrations corresponds closely with the time course of minimal phototoxic doses found in previous studies. Because tissue concentrations after topical administration of 8-methoxypsoralen (bath and cream) were high compared with plasma concentrations and because they were less variable and occurred at better predictable time points than those after oral administration, we suggest that topical PUVA is superior to systemic PUVA, at least from a pharmacokinetic point of view.

A comparison of bathwater and oral delivery of 8-methoxypsoralen in PUVA therapy for plaque psoriasis. [2000.03]
Bath-PUVA is an alternative to oral-PUVA for the treatment of psoriasis. This study compares the effectiveness of the two methods in two groups, each consisting of 17 patients with plaque psoriasis... It is suitable for those taking other systemic medications and we recommend it as a valuable therapeutic option that should be available at all treatment centres.

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Clinical Trials Related to 8-MOP (Methoxsalen)

Safety and Efficacy of Extracorporeal Photoimmune Therapy With UVADEX for the Treatment of Crohn's Disease [Completed]
his study will explore the safety and activity of ECP treatment with UVADEX in inducing a clinical response (i. e., a CDAI decrease greater than or equal to 100 from baseline and/or a CDAI < 150) over a 12-week period in moderately active Crohn's disease (CDAI greater than or equal to 220 to < 450) patients who are refractory or intolerant to immunosuppressants and/or anti-TNF agents. This study will also assess response to continued treatment during a 12-week Extension Period in patients who have a clinical response at Week 12 of the Treatment Period and elect to participate in the Extension Period.

A Safety and Efficacy Study of Uvadex and Extracorporeal Photopheresis (ECP) in Chronic Graft Versus Host Disease [Active, not recruiting]
The purpose of this study is to evaluate the safety and effectiveness of extracorporeal photopheresis therapy when added to standard drug therapies administered to patients with moderate to severe chronic graft-versus-host disease.

Extracorporeal Photoimmune Therapy With UVADEX for the Treatment of Acute Graft Versus-Host Disease [Terminated]
The purpose of this study is to compare the safety and efficacy of ECP treatment combined with high dose corticosteroids versus high dose corticosteroids alone, in the treatment of patients with newly diagnosed acute GvHD (Grades II to III) that developed within 100 days following an allo HPCT.

UVADEX and ECP for the Treatment of Pediatric Patients With Steroid Refractory Acute Graft Versus Host Disease [Not yet recruiting]
This is a single-arm, open-label, multicenter study of the efficacy of UVADEX (methoxsalen) Sterile Solution in conjunction with THERAKOS CELLEX Photopheresis Systems in pediatric patients with steroid-refractory aGvHD. The study is composed of Screening, Treatment, and Follow-up Periods.

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Page last updated: 2009-10-20

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