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Spironolactone for the Treatment of Melasma

Primary Purpose

Melasma

Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Spironolactone 50Mg Tablet
Spironolactone 100Mg Tablet
Spironolactone 200Mg
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melasma focused on measuring spironolactone

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Subject must have clinically diagnosed melasma, with an inadequate response to other treatment modalities, including but not limited to depigmenting agents, topical retinoids, topical steroids, peeling agents, laser and light therapies and combined topical creams.
  2. Subject must be a female.
  3. Subject must be 18-70 years of age.
  4. Women of child-bearing potential must be on effective contraception. Acceptable methods of contraception include oral contraceptive pills (OCPs), hormonal or copper IUDs, contraceptive implants, contraceptive injections, birth control patches, vaginal rings, condom, sponge, diaphragm with spermicide, or prior surgical sterilization.
  5. Subject must provide written informed consent prior to any study-related procedures being performed.
  6. Subject must be willing to comply with all clinical study procedures.

Exclusion Criteria:

  1. Subject is a pregnant or nursing female.
  2. Subject has previously received spironolactone or another antiandrogenic treatment for melasma.
  3. Subject is hyperkalemic, defined by a potassium level of greater than 5.1 mEq/liter.
  4. Subjects with Addison's disease.
  5. Subjects taking eplerenone or other potassium-sparing diuretics, lithium, cholestyramine, ACE inhibitors/angiotensin II antagonists/aldosterone blockers, or NSAIDS.
  6. Subjects receiving potassium supplementation.
  7. Subjects with history of renal disease or an eFGR < 30.
  8. Subjects with acute or chronic liver failure.
  9. Subject has an acute psychiatric condition that impairs ability to give consent or follow study protocols.

Sites / Locations

  • Medical University of SC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

spironolactone 50 mg

spironolactone 100 mg

spironolactone 200 mg

Arm Description

Oral administration of spironolactone 50 mg once daily for 12 weeks

Oral administration of spironolactone 100 mg once daily for 12 weeks

Oral administration of spironolactone 200 mg once daily for 12 weeks

Outcomes

Primary Outcome Measures

Proportion of patients achieving clinical response
Clinical response defined as a 30% reduction in physician-assigned melanoma severity score on an anchored 100 mm visual analogue scale (VAS) with a minimum of 0 representing clear (better outcome) and a maximum of 100 representing very severe (worse outcome)

Secondary Outcome Measures

Proportion of patients achieving clinical response
Clinical response defined as a 30% reduction in physician-assigned melanoma severity score on an anchored 100 mm visual analogue scale (VAS) with a minimum of 0 representing clear (better outcome) and a maximum of 100 representing very severe (worse outcome)
Change in Dermatology Life Quality Index (DLQI)
Dermatology-specific quality of life questionnaire consisting of 10 items concerning patients' perception of the impact of skin diseases on different aspects of their health-related quality of life over the last week. Each item is scored on a four point likert scale and the DLQI is calculated by summing the score of each question resulting in a minimum of 0 and a maximum of 30. The higher the score, the greater impairment of the patients QoL.
Tolerability of spironolactone as measured by incidence of treatment-related adverse events
Patient reported and physician observed
Comparing proportion of patients achieving clinical response between the three treatment arms: 50 mg, 100 mg, and 200 mg of spironolactone
Will estimate the difference between the proportions in the treatment arms

Full Information

First Posted
April 18, 2019
Last Updated
July 2, 2020
Sponsor
Medical University of South Carolina
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1. Study Identification

Unique Protocol Identification Number
NCT03953209
Brief Title
Spironolactone for the Treatment of Melasma
Official Title
Spironolactone for the Treatment of Melasma: a Prospective, Open-label Proof-of-concept and Dose-ranging Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Conflict with funding
Study Start Date
March 5, 2020 (Anticipated)
Primary Completion Date
January 2021 (Anticipated)
Study Completion Date
January 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
The purpose of this study is to prospectively gather data on the efficacy and tolerability of spironolactone to treat refractory melasma and to compare treatment response of randomized 50 mg, 100mg, and 200mg per day dosing.
Detailed Description
Melasma is a common, acquired condition of the skin characterized by symmetric reticulated hyperpigmented patches, most often of the central face and mandible. An array of treatment modalities encompassing topical, oral, procedural, and combination therapies have been used to treat the disorder, with varying levels of immediate and long-term efficacy. Current treatment options are often unsuccessful in inducing complete disease remission. The tolerability of certain treatments is a valid concern, with adverse reactions such as irritation, peeling, burning, and post-inflammatory hyperpigmentation a common occurrence. Antiandrogens like spironolactone have been successfully used as adjunctive treatment for melasma. However, evidence for its off-label use for this purpose remains anecdotal. Clinical data regarding its efficacy and dosing are absent from the literature and are likely barriers to the drug's use in melasma. The high relapse rates and unfavorable side effect profiles of traditional treatment regimens underlie the need for an improved multimodal approach. This prospective, randomized trial seeks to obtain information about the efficacy and tolerability of spironolactone to treat refractory melasma to guide future studies and clinical decision making. Participants will be randomized to one of the three dosage groups and take the study drug for 12 weeks. Outcomes will be assessed at baseline, week 6, week 12, and week 16. Subjects may opt to participate in a treatment extension period of up to 9 additional months, in which they will return to clinic monthly for outcome assessment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melasma
Keywords
spironolactone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
spironolactone 50 mg
Arm Type
Experimental
Arm Description
Oral administration of spironolactone 50 mg once daily for 12 weeks
Arm Title
spironolactone 100 mg
Arm Type
Experimental
Arm Description
Oral administration of spironolactone 100 mg once daily for 12 weeks
Arm Title
spironolactone 200 mg
Arm Type
Experimental
Arm Description
Oral administration of spironolactone 200 mg once daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Spironolactone 50Mg Tablet
Other Intervention Name(s)
Aldactone
Intervention Description
Oral administration of one spironolactone 50 mg tablet once daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Spironolactone 100Mg Tablet
Other Intervention Name(s)
Aldactone
Intervention Description
Oral administration of one spironolactone 100 mg tablet once daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Spironolactone 200Mg
Other Intervention Name(s)
Aldactone
Intervention Description
Oral administration of two spironolactone 100 mg tablets once daily for 12 weeks
Primary Outcome Measure Information:
Title
Proportion of patients achieving clinical response
Description
Clinical response defined as a 30% reduction in physician-assigned melanoma severity score on an anchored 100 mm visual analogue scale (VAS) with a minimum of 0 representing clear (better outcome) and a maximum of 100 representing very severe (worse outcome)
Time Frame
baseline and 12 weeks
Secondary Outcome Measure Information:
Title
Proportion of patients achieving clinical response
Description
Clinical response defined as a 30% reduction in physician-assigned melanoma severity score on an anchored 100 mm visual analogue scale (VAS) with a minimum of 0 representing clear (better outcome) and a maximum of 100 representing very severe (worse outcome)
Time Frame
week 6, week 16, and optional treatment extension period visits lasting up to 1 yr
Title
Change in Dermatology Life Quality Index (DLQI)
Description
Dermatology-specific quality of life questionnaire consisting of 10 items concerning patients' perception of the impact of skin diseases on different aspects of their health-related quality of life over the last week. Each item is scored on a four point likert scale and the DLQI is calculated by summing the score of each question resulting in a minimum of 0 and a maximum of 30. The higher the score, the greater impairment of the patients QoL.
Time Frame
baseline, week 6, week 12, week 16, and week 6, week 16, and optional treatment extension period visits lasting up to 1 yr
Title
Tolerability of spironolactone as measured by incidence of treatment-related adverse events
Description
Patient reported and physician observed
Time Frame
baseline, week 6, week 12, week 16, and week 6, week 16, and optional treatment extension period visits lasting up to 1 yr
Title
Comparing proportion of patients achieving clinical response between the three treatment arms: 50 mg, 100 mg, and 200 mg of spironolactone
Description
Will estimate the difference between the proportions in the treatment arms
Time Frame
week 6, week 12, week 16, and week 6, week 16, and optional treatment extension period visits lasting up to 1 yr

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Males will be excluded from this study due to the high incidence of gynecomastia and sexual dysfunction seen in spironolactone use at higher doses in men. The drug is not routinely used to treat dermatologic conditions in men due to its poor tolerability.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject must have clinically diagnosed melasma, with an inadequate response to other treatment modalities, including but not limited to depigmenting agents, topical retinoids, topical steroids, peeling agents, laser and light therapies and combined topical creams. Subject must be a female. Subject must be 18-70 years of age. Women of child-bearing potential must be on effective contraception. Acceptable methods of contraception include oral contraceptive pills (OCPs), hormonal or copper IUDs, contraceptive implants, contraceptive injections, birth control patches, vaginal rings, condom, sponge, diaphragm with spermicide, or prior surgical sterilization. Subject must provide written informed consent prior to any study-related procedures being performed. Subject must be willing to comply with all clinical study procedures. Exclusion Criteria: Subject is a pregnant or nursing female. Subject has previously received spironolactone or another antiandrogenic treatment for melasma. Subject is hyperkalemic, defined by a potassium level of greater than 5.1 mEq/liter. Subjects with Addison's disease. Subjects taking eplerenone or other potassium-sparing diuretics, lithium, cholestyramine, ACE inhibitors/angiotensin II antagonists/aldosterone blockers, or NSAIDS. Subjects receiving potassium supplementation. Subjects with history of renal disease or an eFGR < 30. Subjects with acute or chronic liver failure. Subject has an acute psychiatric condition that impairs ability to give consent or follow study protocols.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dirk Elston, MD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of SC
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Spironolactone for the Treatment of Melasma

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