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Spironolactone for the Treatment of Melasma

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ClinicalTrials.gov Identifier: NCT03953209
Recruitment Status : Not yet recruiting
First Posted : May 16, 2019
Last Update Posted : June 7, 2019
Sponsor:
Information provided by (Responsible Party):
Dirk Elston, MD, Medical University of South Carolina

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.

Condition or disease Intervention/treatment Phase
Melasma Drug: Spironolactone 50Mg Tablet Drug: Spironolactone 100Mg Tablet Drug: Spironolactone 200Mg Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Spironolactone for the Treatment of Melasma: a Prospective, Open-label Proof-of-concept and Dose-ranging Study
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: spironolactone 50 mg
Oral administration of spironolactone 50 mg once daily for 12 weeks
Drug: Spironolactone 50Mg Tablet
Oral administration of one spironolactone 50 mg tablet once daily for 12 weeks
Other Name: Aldactone

Experimental: spironolactone 100 mg
Oral administration of spironolactone 100 mg once daily for 12 weeks
Drug: Spironolactone 100Mg Tablet
Oral administration of one spironolactone 100 mg tablet once daily for 12 weeks
Other Name: Aldactone

Experimental: spironolactone 200 mg
Oral administration of spironolactone 200 mg once daily for 12 weeks
Drug: Spironolactone 200Mg
Oral administration of two spironolactone 100 mg tablets once daily for 12 weeks
Other Name: Aldactone




Primary Outcome Measures :
  1. Proportion of patients achieving clinical response [ Time Frame: baseline and 12 weeks ]
    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 :
  1. Proportion of patients achieving clinical response [ Time Frame: week 6, week 16, and optional treatment extension period visits lasting up to 1 yr ]
    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)

  2. Change in Dermatology Life Quality Index (DLQI) [ 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 ]
    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.

  3. Tolerability of spironolactone as measured by incidence of treatment-related adverse events [ 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 ]
    Patient reported and physician observed

  4. Comparing proportion of patients achieving clinical response between the three treatment arms: 50 mg, 100 mg, and 200 mg of spironolactone [ Time Frame: week 6, week 12, week 16, and week 6, week 16, and optional treatment extension period visits lasting up to 1 yr ]
    Will estimate the difference between the proportions in the treatment arms



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   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.
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03953209


Contacts
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Contact: Chelsea Eason, BA 803-238-0199 easonch@musc.edu
Contact: Mark Lynch 843-876-5074 lynchd@musc.edu

Locations
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United States, South Carolina
Medical University of SC Not yet recruiting
Charleston, South Carolina, United States, 29425
Contact: Chelsea Eason, BA         
Sponsors and Collaborators
Medical University of South Carolina
Investigators
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Principal Investigator: Dirk Elston, MD Medical University of South Carolina

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Responsible Party: Dirk Elston, MD, Dept. Chair Dermatology, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT03953209     History of Changes
Other Study ID Numbers: 00076765
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: June 7, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Keywords provided by Dirk Elston, MD, Medical University of South Carolina:
spironolactone

Additional relevant MeSH terms:
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Melanosis
Hyperpigmentation
Pigmentation Disorders
Skin Diseases
Spironolactone
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents