Trial Outcomes & Findings for Hydroxychloroquine for the Treatment of Hidradenitis Suppurativa (NCT NCT03275870)

NCT ID: NCT03275870

Last Updated: 2020-04-02

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 17 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2020-04-02

Participant Flow

Participant milestones

Measure	Hydroxychloroquine Treatment Hydroxychloroquine 200mg BID for 6 months Hydroxychloroquine: Treatment of patients with hidradenitis suppurativa with hydroxychloroquine 200mg BID for 6 months
Overall Study STARTED	17
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	14

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Hydroxychloroquine for the Treatment of Hidradenitis Suppurativa

Baseline characteristics by cohort

Measure	Hydroxychloroquine Treatment n=17 Participants Hydroxychloroquine 200mg BID for 6 months Hydroxychloroquine: Treatment of patients with hidradenitis suppurativa with hydroxychloroquine 200mg BID for 6 months
Age, Continuous	38.9 years n=93 Participants
Sex: Female, Male Female	14 Participants n=93 Participants
Sex: Female, Male Male	3 Participants n=93 Participants
Race/Ethnicity, Customized Caucasian	14 Participants n=93 Participants
Race/Ethnicity, Customized Black	3 Participants n=93 Participants
Region of Enrollment United States	17 participants n=93 Participants

PRIMARY outcome

Timeframe: 6 months

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

Outcome measures

Measure	Hydroxychloroquine Treatment n=3 Participants Hydroxychloroquine 200mg BID for 6 months Hydroxychloroquine: Treatment of patients with hidradenitis suppurativa with hydroxychloroquine 200mg BID for 6 months
Change in Disease Severity Baseline sartorius score	23.3 score on a scale Standard Deviation 16.2
Change in Disease Severity 6 month sartorius score	17.7 score on a scale Standard Deviation 14.4

SECONDARY outcome

Timeframe: 6 months

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.

Outcome measures

Measure	Hydroxychloroquine Treatment n=3 Participants Hydroxychloroquine 200mg BID for 6 months Hydroxychloroquine: Treatment of patients with hidradenitis suppurativa with hydroxychloroquine 200mg BID for 6 months
Change in Quality of Life Baseline DLQI score	14.7 score on a scale Standard Deviation 11
Change in Quality of Life 6 month DLQI score	6 score on a scale Standard Deviation 7.9

Adverse Events

Hydroxychloroquine Treatment

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Hydroxychloroquine Treatment n=17 participants at risk Hydroxychloroquine 200mg BID for 6 months Hydroxychloroquine: Treatment of patients with hidradenitis suppurativa with hydroxychloroquine 200mg BID for 6 months
Gastrointestinal disorders Nausea	11.8% 2/17 • Number of events 2 • 13 months Patients were periodically asked about side effects by a telephone call 1 month after starting treatment, at the 3 and 6 month follow up visit. They were evaluated for blurred vision, changes in vision, diarrhea, nausea, vomiting, headache, pruritus, anorexia and abdominal pain
Nervous system disorders headache	5.9% 1/17 • Number of events 1 • 13 months Patients were periodically asked about side effects by a telephone call 1 month after starting treatment, at the 3 and 6 month follow up visit. They were evaluated for blurred vision, changes in vision, diarrhea, nausea, vomiting, headache, pruritus, anorexia and abdominal pain
Skin and subcutaneous tissue disorders urticaria	5.9% 1/17 • Number of events 1 • 13 months Patients were periodically asked about side effects by a telephone call 1 month after starting treatment, at the 3 and 6 month follow up visit. They were evaluated for blurred vision, changes in vision, diarrhea, nausea, vomiting, headache, pruritus, anorexia and abdominal pain
Psychiatric disorders Depression	5.9% 1/17 • Number of events 1 • 13 months Patients were periodically asked about side effects by a telephone call 1 month after starting treatment, at the 3 and 6 month follow up visit. They were evaluated for blurred vision, changes in vision, diarrhea, nausea, vomiting, headache, pruritus, anorexia and abdominal pain
Eye disorders blurred vision	5.9% 1/17 • Number of events 1 • 13 months Patients were periodically asked about side effects by a telephone call 1 month after starting treatment, at the 3 and 6 month follow up visit. They were evaluated for blurred vision, changes in vision, diarrhea, nausea, vomiting, headache, pruritus, anorexia and abdominal pain

Additional Information

Dr. Elena Gonzalez Brant, PI

Beth Israel Lahey Health

Phone: 6173191221

Email: emgbrant@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place