Page last updated: 2024-10-26

doxazosin and Leiomyomatosis

doxazosin has been researched along with Leiomyomatosis in 1 studies

Doxazosin: A prazosin-related compound that is a selective alpha-1-adrenergic blocker.
doxazosin : A member of the class of quinazolines that is quinazoline substituted by an amino group at position 4, methoxy groups at positions 6 and 7 and a piperazin-1-yl group at position 2 which in turn is substituted by a 2,3-dihydro-1,4-benzodioxin-2-ylcarbonyl group at position 4. An antihypertensive agent, it is used in the treatment of high blood pressure.

Leiomyomatosis: The state of having multiple leiomyomas throughout the body. (Stedman, 25th ed)

Research

Studies (1)

TimeframeStudies, this research(%)All Research%
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's1 (100.00)29.6817
2010's0 (0.00)24.3611
2020's0 (0.00)2.80

Authors

AuthorsStudies
Batchelor, RJ1
Lyon, CC1
Highet, AS1

Clinical Trials (1)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Randomized Pilot Study for the Treatment of Cutaneous Leiomyomas With Botulinum Toxin[NCT00971620]Phase 218 participants (Actual)Interventional2008-11-17Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Change in Post-Ice Provocation Visual Analog Score (VAS) Between Week 12 and Week 24

The VAS is a commonly used validated tool for assessment of pain. The 10-cm VAS was used to assess current patient pain/discomfort before and after application of ice to study lesions. A clinically meaningful change in chronic pain intensity using the VAS has been determined as a reduction of 2 points or 30%. Scale is 0-10. 10 denotes worse pain than 0. (NCT00971620)
Timeframe: Between week 12 and 24

InterventionScore (Median)
BTX-A4.10
Placebo/Saline-0.30

Change in Worst Lesional Pain in the Past Week Based on Brief Pain Inventory

Change in worst lesional pain in the past week based on Brief Pain Inventory (BPI) from Week 0 to Week 4 in treated patients versus controls. The BPI uses an arbitrary units on a 0-10 scale. For the purposes of the statistical calculation, a difference of 1 standard deviation between groups at baseline vs. week 4 was considered significant. Any BPI value above zero (no pain) is abnormal. The mean change indicates mean change in pain score. (NCT00971620)
Timeframe: Between week 0 and week 4

Interventionunits on a scale (Mean)
BTX-A-2.50
Placebo/Saline-1.26

Comparison of Change in Skin Related Quality of Life by Total Dermatology Life Quality Index (DLQI) at Week 0 vs. Week 4

The DLQI is a 10-question quality of life survey which has been extensively validated and frequently used in dermatologic disorders such as atopic dermatitis, acne, and psoriasis. Score is 0-30 based on 10 questions. The higher the score, the more quality of life is impaired. (NCT00971620)
Timeframe: Week 0 vs. week 4

InterventionUnits on a scale (Median)
BTX-A-4.00
Placebo/Saline0.00

Immunohistochemical Staining of Cutaneous Leiomyomas for Acetylcholinesterase (AchE) Before (i.e.,Week 0) and 12 Weeks After Botulinum Toxin Administration

AchE staining was scored as 0 (none), 1 (rare), 2 (scattered), or 3 (focal or greater). (NCT00971620)
Timeframe: Week 0 vs. week 12

InterventionScore (Median)
BTX-A1.00
Placebo/Saline0.00

Immunohistochemical Staining of Cutaneous Leiomyomas for C-fos Before (i.e., Week 0) and 12 Weeks After Botulinum Toxin Administration

c-fos, a marker of neuronal activation after pain stimulation, was scored as 0 (none), 1 (scattered), 2 (<66% of tumor cells), or 3 (≥66% of tumor cells). (NCT00971620)
Timeframe: Week 0 vs. week 12

InterventionScore (Median)
BTX-A-1.00
Placebo/Saline0.00

Median Change in Average Pain Between Two Arms

Change in average pain was assessed by the Brief Pain Inventory (BPI). The BPI is a validated pain assessment tool that assesses severity of pain, location of pain, impact of pain on daily functions, pain medications, and amount of pain relief in the past 24 hours or past week (e.g. scale of 0-10 (worst pain)). (NCT00971620)
Timeframe: Between weeks 0 and week 4

InterventionScore (Median)
BTX-A0.00
Placebo/Saline0.00

Number of Participants With Adverse Events

Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module. (NCT00971620)
Timeframe: 37 months

Interventionparticipants (Number)
BTX-A4
Placebo/Saline5

Specific Skin Pain-Related Question on the Dermatology Life Quality Index

"The DLQI is a 10-question quality of life survey which has been extensively validated and frequently used in dermatologic disorders such as atopic dermatitis, acne, and psoriasis. Participants response to the question Over the last week, how itchy, sore, painful or stinging has your skin been? was assessed by the Dermatology Life Quality Index. This outcome refers to a single specific question on the DLQI, so the range for this outcome is 0-3. Lower values in the DLQI indicate less impairment (or greater improvement) in life quality from the skin disease." (NCT00971620)
Timeframe: Week 0 vs. week 4

InterventionUnits on a scale (Median)
BTX-A-1.00
Placebo/Saline0.00

Visual Analog Scale (VAS) of Patient Perceived Pain at Leiomyoma Site Prior to Ice Provocation at Week 0 vs. Week 4

The VAS is a commonly used validated tool for assessment of pain. For this measure, a 10-cm VAS was used to assess current patient pain/discomfort before application of ice to study lesions at week 0 and week 4. A clinically meaningful change in chronic pain intensity using the VAS has been determined as a reduction of 2 points or 30%. Range is 0-10; 0 is no pain and 10 is worst possible pain. (NCT00971620)
Timeframe: Week 0 vs. week 4

InterventionScore (Median)
BTX-A0.00
Placebo/Saline0.40

Worst Pain Severity

Pain severity was assessed by the Brief Pain Inventory (BPI). The BPI is a validated pain assessment tool that assesses severity of pain, location of pain, impact of pain on daily functions, pain medications, and amount of pain relief in the past 24 hours or past week (e.g. scale of 0-10 (worst pain)). This outcome was based on a single 0-10 question on the BPI. (NCT00971620)
Timeframe: Week 0 vs. week 4

InterventionScore (Median)
BTX-A-2.25
Placebo/Saline-0.75

Percentage of Patients With a Change in Average Pain Score

Average pain was determined from a 0-10 scale question on the Brief Pain Inventory (BPI). 10 denotes worse pain. (NCT00971620)
Timeframe: Week 0 score vs. week 4 score

,
Interventionpercentage of patients (Number)
>50% pain reduction≤50% pain reductionNo change in painIncreased painMissing
BTX-A440222211
Placebo/Saline2211332211

Percentage of Patients With a Change in Post-Ice Visual Analog Score (VAS) Between Week 0 and Week 4

The VAS is a commonly used validated tool for assessment of pain. The 10-cm VAS was used to assess current patient pain/discomfort before and after application of ice to study lesions. A clinically meaningful change in chronic pain intensity using the VAS has been determined as a reduction of 2 points or 30%. Scale is 0-10. 10 = worse pain. (NCT00971620)
Timeframe: Week 0 vs. week 4

,
Interventionpercentage of patients (Number)
>50% pain reduction≤50% pain reductionNo change in painIncreased painMissing
BTX-A33440220
Placebo/Saline33440220

Percentage of Patients With a Change in Pre-Ice Visual Analog Score (VAS) Between Week 0 and Week 4

The VAS is a commonly used validated tool for assessment of pain. The 10-cm VAS was used to assess current patient pain/discomfort before and after application of ice to study lesions. A clinically meaningful change in chronic pain intensity using the VAS has been determined as a reduction of 2 points or 30%. Scale of 0-10. 10 = worse pain. (NCT00971620)
Timeframe: Week 0 vs. week 4

,
Interventionpercentage of patients (Number)
>50% pain reduction≤50% pain reductionNo change in painIncreased painMissing
BTX-A223301133
Placebo/Saline110115522

Other Studies

1 other study available for doxazosin and Leiomyomatosis

ArticleYear
Successful treatment of pain in two patients with cutaneous leiomyomata with the oral alpha-1 adrenoceptor antagonist, doxazosin.
    The British journal of dermatology, 2004, Volume: 150, Issue:4

    Topics: Adrenergic alpha-Antagonists; Adult; Doxazosin; Female; Humans; Leiomyomatosis; Middle Aged; Pain; S

2004