MelasmaPhase 1NCT03953209
Spironolactone for the Treatment of Melasma
A Phase 1 study testing Spironolactone 50Mg Tablet, Spironolactone 100Mg Tablet and Spironolactone 200Mg in people with Melasma, run by Medical University of South Carolina at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Melasma
- What is being tested?
- Spironolactone 50Mg Tablet, Spironolactone 100Mg Tablet and Spironolactone 200Mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Mar 2020to 1 Jan 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of SC
Charleston, South Carolina, 29425
About this study
Official title: Spironolactone for the Treatment of Melasma: a Prospective, Open-label Proof-of-concept and Dose-ranging Study
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.
Read the 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.
- Conditions
- Melasma
- Being tested
- Spironolactone 50Mg Tablet, Spironolactone 100Mg Tablet, Spironolactone 200Mg
- Keywords
- spironolactone
- Medical subject headings
- Melanosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spironolactone 50Mg TabletDrug
Also called Aldactone
Oral administration of one spironolactone 50 mg tablet once daily for 12 weeks
Spironolactone 100Mg TabletDrug
Also called Aldactone
Oral administration of one spironolactone 100 mg tablet once daily for 12 weeks
Spironolactone 200MgDrug
Also called Aldactone
Oral administration of two spironolactone 100 mg tablets once daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| spironolactone 50 mg | Experimental | Oral administration of spironolactone 50 mg once daily for 12 weeks Receives: Drug: Spironolactone 50Mg Tablet |
| spironolactone 100 mg | Experimental | Oral administration of spironolactone 100 mg once daily for 12 weeks Receives: Drug: Spironolactone 100Mg Tablet |
| spironolactone 200 mg | Experimental | Oral administration of spironolactone 200 mg once daily for 12 weeks Receives: Drug: Spironolactone 200Mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: baseline and 12 weeks
Secondary outcomes (4)
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)
Measured: week 6, week 16, and optional treatment extension period visits lasting up to 1 yr
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.
Measured: baseline, week 6, week 12, week 16, and week 6, week 16, and optional treatment extension period visits lasting up to 1 yr
Tolerability of spironolactone as measured by incidence of treatment-related adverse events
Patient reported and physician observed
Measured: baseline, week 6, week 12, week 16, and week 6, week 16, and optional treatment extension period visits lasting up to 1 yr
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
Measured: week 6, week 12, week 16, and week 6, week 16, and optional treatment extension period visits lasting up to 1 yr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2019
- Study start5 Mar 2020
- Primary completion1 Jan 2021
- Study completion1 Jan 2021
Why it stopped: Conflict with funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelasmaStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dirk Elston, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03953209
- Sponsor's protocol ID
- 00076765
- Status last verified
- Aug 2024
- First submitted
- 18 Apr 2019
- Last updated
- 4 Sep 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spironolactone for the Treatment of Melasma: a Prospective, Open-label Proof-of-concept and Dose-ranging Study
- ClinicalTrials.gov ID
- NCT03953209
- Acronym / sponsor ID
- 00076765
- Conditions
- Melasma
- Keywords
- spironolactone
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Conflict with funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 5 Mar 2020 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 16 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| spironolactone 50 mg | Experimental | Drug: Spironolactone 50Mg TabletOral administration of spironolactone 50 mg once daily for 12 weeks |
| spironolactone 100 mg | Experimental | Drug: Spironolactone 100Mg TabletOral administration of spironolactone 100 mg once daily for 12 weeks |
| spironolactone 200 mg | Experimental | Drug: Spironolactone 200MgOral administration of spironolactone 200 mg once daily for 12 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spironolactone 50Mg TabletAlso: AldactoneOral administration of one spironolactone 50 mg tablet once daily for 12 weeks | Drug | spironolactone 50 mg |
| Spironolactone 100Mg TabletAlso: AldactoneOral administration of one spironolactone 100 mg tablet once daily for 12 weeks | Drug | spironolactone 100 mg |
| Spironolactone 200MgAlso: AldactoneOral administration of two spironolactone 100 mg tablets once daily for 12 weeks | Drug | spironolactone 200 mg |
Primary outcome
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)
4 secondary outcomes
Proportion of patients achieving clinical response
Time frame: week 6, week 16, and optional treatment extension period visits lasting up to 1 yr
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
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
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dirk Elston, MD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Spironolactone 50Mg Tablet, Spironolactone 100Mg Tablet and Spironolactone 200Mg in people with Melasma, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients achieving clinical response (time frame: baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2024.