Acne & Hormonal Acne Support
GelTopicalNon sterile Rx only

Spironolactone 5% Topical Gel (WO6® Anhydrous)

Anhydrous Base

A compounded 5% spironolactone gel in WO6 anhydrous base, prepared in Chino, CA to a prescriber's order for topical use on acne prone skin.

Reviewed by Linda Pungpravat, Compounding Pharmacist, RPh Mixwell Compounding Pharmacy, Chino, CA

  • USP <795> compliant
  • USP <800> hazardous drug lab
  • PCCA member

Clinical Advantages

  • Applied topically
  • Custom strength available
  • Preservative free
  • Fragrance free
  • Dye free option

How It Works

What is Spironolactone 5% Topical Gel?

Spironolactone 5% Topical Gel is a compounded preparation of spironolactone, an aldosterone blocker with antiandrogen activity, in a water free gel base. It is prepared by prescription for application to the skin, most often by dermatology practices managing acne in patients who want to avoid or supplement an oral medicine.

How it works

  1. Spironolactone blocks androgen receptors, and androgens drive sebum production in the skin's oil glands [1].
  2. Applying it to the skin places the drug where the sebaceous glands are, rather than throughout the body.
  3. WO6 is an anhydrous gel base with water activity below 0.6, which places it in the nonaqueous category under USP 795 [6].
  4. The prescriber sets the strength, and 5% is the concentration used in the published randomized trial [2].

When prescribers choose it

  • Dermatology practices treating acne in patients who prefer a topical over oral spironolactone
  • Prescribers whose patients had side effects on oral spironolactone
  • Prescribers for whom the approved topical antiandrogen is not a fit or not accessible
  • Practices combining a topical antiandrogen with other acne therapies

Clinical Details

What does the evidence show?
  • Afzali and colleagues (2012, Journal of Dermatological Treatment) randomized 78 patients with mild to moderate acne to 5% spironolactone gel or placebo. The gel reduced total lesion count compared with placebo, but the difference in acne severity index was not statistically significant [2].
  • A 2025 meta-analysis in Naunyn-Schmiedeberg's Archives of Pharmacology pooled seven randomized trials of oral and topical spironolactone covering 643 people. It found no significant difference in comedone or pustule counts over 6 to 8 weeks in the randomized trials, while single arm studies reported improvement after 8 weeks [3].
  • Ayatollahi and colleagues (2021, Health Science Reports) reported a pilot study of 5% spironolactone cream in acne [4].
  • The 2024 American Academy of Dermatology acne guideline conditionally recommends oral spironolactone and conditionally recommends topical clascoterone, an FDA approved topical androgen receptor inhibitor [1].

Findings come from the cited studies and do not promise any individual outcome.

Why is it compounded, and how is it typically used?

Why it is compounded

Spironolactone is FDA approved only as oral tablets and an oral suspension, so no topical spironolactone product exists [5]. An approved topical antiandrogen, clascoterone 1% cream, is available for acne [1]. A prescriber orders compounded spironolactone gel when they want this specific active applied to the skin for a particular patient.

Dosage forms and strengths

  • Strength set by the prescriber, with 5% used in the published trial [2]
  • WO6 anhydrous gel base, formulated without water
  • Dye free and fragrance free by request
  • Can be prescribed alongside other topical acne therapies

Evidence for topical spironolactone comes from small trials with mixed results [2][3]. Application frequency, area, and duration are the prescriber's decision.

How Mixwell prepares it

Mixwell compounds this gel in Chino, California under USP 795 standards for non sterile preparations [6]. Because WO6 has water activity below 0.6, it falls in the nonaqueous category, which carries longer default beyond use dates than water based preparations [6]. Our pharmacist confirms the strength, container, and beyond use date before compounding, and the label carries storage instructions. Batch records document every preparation, and finished gels ship across California.

Safety information

Topical application is intended to keep the drug in the skin, and adverse effects reported in the topical trials were mainly local, such as dryness or irritation [2][3]. Spironolactone carries a warning on tumorigenicity based on chronic toxicity studies in rats exposed to up to 150 times human doses [1].

Spironolactone labeling states that, based on its mechanism and animal studies, it may affect sex differentiation of a male fetus, and advises avoiding it in pregnancy or informing a pregnant patient of the potential risk to a male fetus [5]. Oral spironolactone can also raise potassium [5]. Prescribers weigh these points for patients who are or may become pregnant. Patient selection, dosing, monitoring, and duration are the prescriber's responsibility.

References
  1. Reynolds RV, Yeung H, Cheng CE, et al. Guidelines of care for the management of acne vulgaris. J Am Acad Dermatol. 2024;90(5):1006.e1 to 1006.e30. doi:10.1016/j.jaad.2023.12.017
  2. Afzali BM, Yaghoobi E, Yaghoobi R, Bagherani N, Dabbagh MA. Comparison of the efficacy of 5% topical spironolactone gel and placebo in the treatment of mild and moderate acne vulgaris: a randomized controlled trial. J Dermatolog Treat. 2012;23(1):21 to 25. PubMed 20964565
  3. Oral and topical spironolactone in acne treatment: a meta-analysis of effectiveness and safety. Naunyn Schmiedebergs Arch Pharmacol. 2025. PubMed 39878821
  4. Ayatollahi A, Samadi A, Bahmanjahromi A, Robati RM. Efficacy and safety of topical spironolactone 5% cream in the treatment of acne: a pilot study. Health Sci Rep. 2021;4(3):e317. doi:10.1002/hsr2.317
  5. CAROSPIR (spironolactone) oral suspension, 25 mg/5 mL. Prescribing information. U.S. Food and Drug Administration, 2017. FDA label
  6. United States Pharmacopeia. General Chapter 795, Pharmaceutical Compounding: Nonsterile Preparations. USP NF. Official November 1, 2023.

What to include on the prescription

  • APIs and strengths
  • Base or vehicle
  • Quantity
  • Directions for use
  • Refills
  • Allergies or dye free needs
Call (909) 378-7301 Fax (909) 378-7071

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Compounded in Chino, CA. Delivered across California.

  • Chino
  • Chino Hills
  • Ontario
  • Pomona
  • Diamond Bar
  • Rancho Cucamonga
  • Eastvale
Mixwell Compounding Pharmacy 13788 Roswell Ave, Ste 158, Chino, CA 91710
(909) 378-7301

Compounded medications are not reviewed or approved by the FDA. Dispensed only with a valid prescription. Mixwell is a non sterile pharmacy and does not prepare sterile products or injectables. Compounded preparations are not presented as superior to commercially available products, and nothing here promises a specific result. Mixwell does not accept insurance. Call for pricing.

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Want to learn more about Spironolactone 5% Topical Gel (WO6® Anhydrous)

Are you a healthcare provider or patient in Chino, Chino Hills, Ontario, Eastvale, Rancho Cucamonga, or Upland? Mixwell Pharmacy provides specialized pharmaceutical support throughout San Bernardino, Los Angeles, and Orange Counties. Contact our Chino laboratory to learn how we facilitate customized Spironolactone 5% Topical Gel (WO6® Anhydrous)for practitioners across Southern California.

(909) 378-7301

Serving Los Angeles County, Orange County, San Bernardino County, Riverside County, Ventura County, and the Inland Empire