Last reviewed · How we verify
Hydroxychloroquine for the Treatment of Hidradenitis Suppurativa
Phase 1, PHASE2 trial testing Hydroxychloroquine in Hidradenitis Suppurativa in 17 participants. Completed in 30 June 2019.
| Lead sponsor | Elena Gonzalez Brant, MD |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 17 |
| Start date | 28 September 2017 |
| Primary completion | 30 June 2019 |
| Estimated completion | 30 June 2019 |
| Sites | 1 location across United States |
Elena Gonzalez Brant, MD
18 and older, any sex, with Hidradenitis Suppurativa or Hidradenitis. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Comparison of baseline and post-treatment Sartorius severity scoring Sartorius scoring: minimum 0, no maximum, higher scores mean a worse outcome
| Group | Value | 95% CI |
|---|---|---|
| Hydroxychloroquine Treatment | 23.3 | ± 16.2 |
| Group | Value | 95% CI |
|---|---|---|
| Hydroxychloroquine Treatment | 17.7 | ± 14.4 |
Comparison of baseline and post-treatment self-reported quality of life Dermatology Life Quality Index score: minimum 0, maximum 30. higher scores mean worse outcome.
| Group | Value | 95% CI |
|---|---|---|
| Hydroxychloroquine Treatment | 14.7 | ± 11 |
| Group | Value | 95% CI |
|---|---|---|
| Hydroxychloroquine Treatment | 6 | ± 7.9 |
Time frame: 13 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Hydroxychloroquine Treatment |
|---|---|---|
| Nausea | Gastrointestinal disorders | — |
| headache | Nervous system disorders | — |
| urticaria | Skin and subcutaneous tissue disorders | — |
| Depression | Psychiatric disorders | — |
| blurred vision | Eye disorders | — |
Data from ClinicalTrials.gov NCT03275870 adverse events section.
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.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
Trials testing the same drug.
Currently open trials in the same condition.
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03275870.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing