NCT03275870

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 8, 2017

Completed
20 days until next milestone

Study Start

First participant enrolled

September 28, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
9 months until next milestone

Results Posted

Study results publicly available

March 24, 2020

Completed
Last Updated

April 2, 2020

Status Verified

March 1, 2020

Enrollment Period

1.8 years

First QC Date

August 31, 2017

Results QC Date

January 23, 2020

Last Update Submit

March 23, 2020

Conditions

Hidradenitis SuppurativaHidradenitisAcne InversaBoilsFollicular Occlusion TriadFollicular Occlusion Tetrad

Outcome Measures

Primary Outcomes (1)

  • Change in Disease Severity

    Comparison of baseline and post-treatment Sartorius severity scoring Sartorius scoring: minimum 0, no maximum, higher scores mean a worse outcome

    6 months

Secondary Outcomes (1)

  • Change in Quality of Life

    6 months

Study Arms (1)

Hydroxychloroquine treatment

EXPERIMENTAL

Hydroxychloroquine 200mg BID for 6 months

Drug: Hydroxychloroquine

Interventions

HydroxychloroquineDRUG

Treatment of patients with hidradenitis suppurativa with hydroxychloroquine 200mg BID for 6 months

Also known as: Plaquenil
Hydroxychloroquine treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with hidradenitis suppurativa Hurley stage I or II

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (15)

  • Gonzalez-Lopez MA, Hernandez JL, Lacalle M, Mata C, Lopez-Escobar M, Lopez-Mejias R, Portilla V, Fuentevilla P, Corrales A, Gonzalez-Vela MC, Gonzalez-Gay MA, Blanco R. Increased prevalence of subclinical atherosclerosis in patients with hidradenitis suppurativa (HS). J Am Acad Dermatol. 2016 Aug;75(2):329-35. doi: 10.1016/j.jaad.2016.03.025. Epub 2016 Jun 8.

    PMID: 27287248BACKGROUND

  • Nicola WG, Khayria MI, Osfor MM. Plasma testosterone level and the male genital system after chloroquine therapy. Boll Chim Farm. 1997 Jan;136(1):39-43.

    PMID: 9080720BACKGROUND

  • Garg A, Lavian J, Lin G, Strunk A, Alloo A. Incidence of hidradenitis suppurativa in the United States: A sex- and age-adjusted population analysis. J Am Acad Dermatol. 2017 Jul;77(1):118-122. doi: 10.1016/j.jaad.2017.02.005. Epub 2017 Mar 9.

    PMID: 28285782BACKGROUND

  • Schlapbach C, Hanni T, Yawalkar N, Hunger RE. Expression of the IL-23/Th17 pathway in lesions of hidradenitis suppurativa. J Am Acad Dermatol. 2011 Oct;65(4):790-798. doi: 10.1016/j.jaad.2010.07.010.

    PMID: 21641076BACKGROUND

  • van der Zee HH, de Ruiter L, van den Broecke DG, Dik WA, Laman JD, Prens EP. Elevated levels of tumour necrosis factor (TNF)-alpha, interleukin (IL)-1beta and IL-10 in hidradenitis suppurativa skin: a rationale for targeting TNF-alpha and IL-1beta. Br J Dermatol. 2011 Jun;164(6):1292-8. doi: 10.1111/j.1365-2133.2011.10254.x. Epub 2011 May 17.

    PMID: 21332464BACKGROUND

  • Matusiak L, Szczech J, Bieniek A, Nowicka-Suszko D, Szepietowski JC. Increased interleukin (IL)-17 serum levels in patients with hidradenitis suppurativa: Implications for treatment with anti-IL-17 agents. J Am Acad Dermatol. 2017 Apr;76(4):670-675. doi: 10.1016/j.jaad.2016.10.042. Epub 2016 Dec 29.

    PMID: 28041632BACKGROUND

  • von der Werth JM, Jemec GB. Morbidity in patients with hidradenitis suppurativa. Br J Dermatol. 2001 Apr;144(4):809-13. doi: 10.1046/j.1365-2133.2001.04137.x.

    PMID: 11298541BACKGROUND

  • Andersen RK, Jemec GB. Treatments for hidradenitis suppurativa. Clin Dermatol. 2017 Mar-Apr;35(2):218-224. doi: 10.1016/j.clindermatol.2016.10.018. Epub 2016 Oct 27.

    PMID: 28274363BACKGROUND

  • Fischer AH, Haskin A, Okoye GA. Patterns of antimicrobial resistance in lesions of hidradenitis suppurativa. J Am Acad Dermatol. 2017 Feb;76(2):309-313.e2. doi: 10.1016/j.jaad.2016.08.001. Epub 2016 Oct 11.

    PMID: 27742173BACKGROUND

  • Kimball AB, Okun MM, Williams DA, Gottlieb AB, Papp KA, Zouboulis CC, Armstrong AW, Kerdel F, Gold MH, Forman SB, Korman NJ, Giamarellos-Bourboulis EJ, Crowley JJ, Lynde C, Reguiai Z, Prens EP, Alwawi E, Mostafa NM, Pinsky B, Sundaram M, Gu Y, Carlson DM, Jemec GB. Two Phase 3 Trials of Adalimumab for Hidradenitis Suppurativa. N Engl J Med. 2016 Aug 4;375(5):422-34. doi: 10.1056/NEJMoa1504370.

    PMID: 27518661BACKGROUND

  • Rainsford KD, Parke AL, Clifford-Rashotte M, Kean WF. Therapy and pharmacological properties of hydroxychloroquine and chloroquine in treatment of systemic lupus erythematosus, rheumatoid arthritis and related diseases. Inflammopharmacology. 2015 Oct;23(5):231-69. doi: 10.1007/s10787-015-0239-y. Epub 2015 Aug 6.

    PMID: 26246395BACKGROUND

  • van den Borne BE, Dijkmans BA, de Rooij HH, le Cessie S, Verweij CL. Chloroquine and hydroxychloroquine equally affect tumor necrosis factor-alpha, interleukin 6, and interferon-gamma production by peripheral blood mononuclear cells. J Rheumatol. 1997 Jan;24(1):55-60.

    PMID: 9002011BACKGROUND

  • Silva JC, Mariz HA, Rocha LF Jr, Oliveira PS, Dantas AT, Duarte AL, Pitta Ida R, Galdino SL, Pitta MG. Hydroxychloroquine decreases Th17-related cytokines in systemic lupus erythematosus and rheumatoid arthritis patients. Clinics (Sao Paulo). 2013 Jun;68(6):766-71. doi: 10.6061/clinics/2013(06)07.

    PMID: 23778483BACKGROUND

  • Hage MP, Al-Badri MR, Azar ST. A favorable effect of hydroxychloroquine on glucose and lipid metabolism beyond its anti-inflammatory role. Ther Adv Endocrinol Metab. 2014 Aug;5(4):77-85. doi: 10.1177/2042018814547204.

    PMID: 25343023BACKGROUND

  • Sharma TS, Wasko MC, Tang X, Vedamurthy D, Yan X, Cote J, Bili A. Hydroxychloroquine Use Is Associated With Decreased Incident Cardiovascular Events in Rheumatoid Arthritis Patients. J Am Heart Assoc. 2016 Jan 4;5(1):e002867. doi: 10.1161/JAHA.115.002867.

    PMID: 26727968BACKGROUND

MeSH Terms

Conditions

Hidradenitis SuppurativaHidradenitisFurunculosis

Interventions

Hydroxychloroquine

Condition Hierarchy (Ancestors)

Skin Diseases, BacterialBacterial InfectionsBacterial Infections and MycosesInfectionsSkin Diseases, InfectiousSuppurationSkin DiseasesSkin and Connective Tissue DiseasesSweat Gland DiseasesStaphylococcal Skin InfectionsStaphylococcal InfectionsGram-Positive Bacterial InfectionsFish DiseasesAnimal Diseases

Intervention Hierarchy (Ancestors)

ChloroquineAminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Limitations and Caveats

We did not reach the target number of participants needed to achieve target power and statistically reliable results leading to unreliable or uninterpretable data.

Results Point of Contact

Title
Dr. Elena Gonzalez Brant, PI
Organization
Beth Israel Lahey Health
emgbrant@gmail.com
6173191221

Study Officials

  • Elena M Gonzalez Brant, MD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 31, 2017

First Posted

September 8, 2017

Study Start

September 28, 2017

Primary Completion

June 30, 2019

Study Completion

June 30, 2019

Last Updated

April 2, 2020

Results First Posted

March 24, 2020

Record last verified: 2020-03

Locations

US(1)