What side effects are associated with this type of intervention?

Spironolactone, a hormonal modulator, is commonly used to treat acne in women and can cause side effects such as menstrual irregularities, breast tenderness, and hyperkalemia. Doxycycline hyclate, an antibiotic, is effective in reducing acne lesions but may lead to gastrointestinal disturbances, photosensitivity, and, less commonly, esophagitis. Both treatments are generally well-tolerated but should be discussed with a healthcare provider to weigh the benefits and potential risks.

What prior FDA approvals exist?

The FDA has approved several treatments for acne that include both hormonal therapies and antibiotics. Hormonal treatments like oral contraceptives containing ethinyl estradiol combined with progestins such as drospirenone or norgestimate have been approved for acne management. Spironolactone, although not specifically FDA-approved for acne, is commonly used off-label for its anti-androgen effects. Antibiotics such as doxycycline hyclate, a tetracycline-class antibiotic, are FDA-approved and widely used for their anti-inflammatory and antibacterial properties in treating moderate to severe acne.

What other types of research exist?

Promising novel alternatives for acne treatment in 2024 include: 1) Clascoterone (Cortexolone 17-alpha propionate) topical cream, which is a topical androgen receptor inhibitor showing efficacy in reducing acne lesions. 2) Sarecycline, a narrow-spectrum tetracycline antibiotic, which has demonstrated effectiveness in treating both facial and truncal acne with a lower risk of antibiotic resistance. 3) Combination therapies such as adapalene-benzoyl peroxide gel, which have shown sustained efficacy and prevention of acne relapse in clinical trials.

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Anti-bacterial

Spironolactone vs Doxycycline for Acne

Phase 4

Recruiting

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Female sex assigned at birth

Age 16-40 years old

Must not have

Sebacia laser treatment within the past 12 months

Treatment with isotretinoin within the past 3 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to week4, week 8, week 12, and week 16

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Drug Has Already Been Approved

Summary

This trial compares two treatments for women with moderate to severe acne. One treatment helps balance hormones to reduce skin oiliness, while the other kills bacteria and reduces inflammation. The goal is to see which treatment is more effective and potentially reduce the need for long-term antibiotic use.

Who is the study for?

This trial is for women aged 16-40 with moderate to severe acne, not pregnant or planning pregnancy. Participants must have at least 10 inflamed pimples and a certain severity score on an acne scale. Excluded are those with allergies to tetracycline antibiotics, heart/liver/renal disease, history of high potassium levels, recent use of specific acne treatments or drugs that interact with the trial medications.

What is being tested?

The study compares Spironolactone (a hormonal therapy) against Doxycycline Hyclate (an antibiotic) in treating women's acne. It aims to see which treatment is more effective while potentially reducing long-term antibiotic use by addressing hormonal factors influencing sebum production.

What are the potential side effects?

Spironolactone may cause menstrual irregularities, breast tenderness, fatigue, and increase potassium levels leading to heart issues. Doxycycline can lead to sun sensitivity, digestive upset like nausea or diarrhea, and rarely causes allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I was assigned female at birth.

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I am between 16 and 40 years old.

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I have acne with at least 10 red bumps and a moderate severity score.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had Sebacia laser treatment in the last year.

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I have not taken isotretinoin in the last 3 months.

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I have a heart condition.

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I have Addison's disease.

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I experience significant drops in blood pressure when standing up.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to week4, week 8, week 12, and week 16

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to week4, week 8, week 12, and week 16

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week4, week 8, week 12, and week 16 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Absolute change in inflammatory papules and pustules

Secondary study objectives

Change in Acne-QoL, an acne-specific quality of life measure

Change in Dermatology Life Quality Index (DLQI), a dermatology-specific quality of life measure

Change in comedonal lesions

+3 more

Side effects data

From 2022 Phase 4 trial • 79 Patients • NCT02169089

Hypotension

Infection

Hyperkalemia

Diabetes related

Surgical

Chest pain/discomfort

Breast tenderness/Gynecomastia

100%

80%

60%

40%

20%

Study treatment Arm

Spironolactone

Placebo

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: SpironolactoneExperimental Treatment1 Intervention

In this arm, participants will receive spironolactone 100mg/day for the entirety of the study. To maximize the generalizability of the study, participants will be allowed to continue their current topical regimen as long as no changes were made in the 4 weeks prior to randomization. No additions to their topical regimen may be made during the study period.

Group II: Doxycycline hyclateActive Control1 Intervention

This arm is an active-comparator arm in which participants will receive doxycycline hyclate 100mg/day for the entirety of the study. To maximize the generalizability of the study, participants will be allowed to continue their current topical regimen as long as no changes were made in the 4 weeks prior to randomization. No additions to their topical regimen may be made during the study period.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Spironolactone

2005

Completed Phase 4

~14580

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Spironolactone, a hormonal modulator, works by blocking androgen receptors and reducing androgen production, which decreases sebum production—a key factor in acne development. This is particularly beneficial for women with hormonally influenced acne. Doxycycline hyclate, an antibiotic, reduces acne by inhibiting bacterial protein synthesis, thereby decreasing the population of acne-causing bacteria and reducing inflammation. Understanding these mechanisms helps patients and doctors choose treatments that target the specific underlying causes of their acne, leading to more effective and personalized care.

[Treatment of acne vulgaris. A comparison of doxycycline versus minocycline].What's new in acne? An analysis of systematic reviews published in 2009-2010.Randomised controlled multiple treatment comparison to provide a cost-effectiveness rationale for the selection of antimicrobial therapy in acne.