Phase 2
Completed N=17
Hydroxychloroquine for the Treatment of Hidradenitis Suppurativa
Hidradenitis suppurativa · Hidradenitis · Acne Inversa · Boils
Source: ClinicalTrials.gov NCT03275870 ↗
Enrolled (actual)
17
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcomePrimary: Change in Disease Severity — 23.3; 17.7 score on a scale — p=0.042
Summary
Hidradenitis suppurativa (HS) is an under-recognized and debilitating disease. Patients suffer from recurring painful abscesses and scarring in their armpits, under the breasts, groin and other areas of the body. The cause of the disease is still unknown and common treatments are only sometimes effective. Overactivity of the immune system has been associated with HS and molecules that cause inflammation have been found in the skin from people with HS. Current therapies have long-term risks including antibiotic resistance and the investigators aim to find new safe and effective therapies for HS.
Hydroxychloroquine is a medication that has been used safely in other diseases for many years. The investigators believe that hydroxychloroquine has the potential to improve HS through multiple mechanisms. Patients enrolled in this study will be treated with hydroxychloroquine for 6 months. The investigators also aim to look at the blood of patients with HS to look for inflammatory molecules that we could possibly target for the treatment of HS. Blood samples will be taken at baseline and following 6 months of treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Disease Severity |
23.3; 17.7 | 0.042 sig |
| SECONDARY Change in Quality of Life |
14.7; 6 | 0.213 |
Eligibility Criteria
Inclusion Criteria
- Patients with hidradenitis suppurativa Hurley stage I or II
Exclusion Criteria
- Current systemic immunosuppression, current use of biologic medication or use of these medications in the prior 3 months, patients with known retinal disease, hepatic disease (HCV, cirrhosis, aspartate aminotransferase or alanine aminotransferase > 2 times the upper limit of normal), psoriasis, porphyria cutanea tarda, platelets < 50,000/ul, leukocytes <4000/ul, or Hb<8g/dl), pregnant patients or women trying to conceive
Data sourced from ClinicalTrials.gov (NCT03275870). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.