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A comparative study to assess the efficacy of Apremilast and doxycycline in hidradenitis suppurativa

A randomised controlled trial to compare the efficacy of Apremilast and Doxycycline in patients of moderate hidradenitis suppurativa.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/05/019103
Enrollment
50
Registered
2019-05-14
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: L732- Hidradenitis suppurativa

Interventions

Intervention1: Apremilast: Apremilast Dose - 30 mg tablet. Frequency - one tablet twice daily Route - Oral Duration - 3 months Control Intervention1: Doxycycline: Doxycycline Dose - 100 mg tablet

Sponsors

Post Graduate institute of medical education and research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed as HS based on the San Francisco modification of Dessau criteria and severity defined as moderate (stage II) by Hurley staging and HS-PGA score more than 3. 2. Age > 18 years. 3. Patients who can give valid consent. 4. Willing for monthly follow-up visits for at least 3 months.

Exclusion criteria

Exclusion criteria: 1. Pregnant and lactating mothers 2. Severe hepatic/renal dysfunction 3. Patients with HIV, Hepatitis B and Hepatitis C 4. Inability to come for monthly follow up visits for 3 months 5. Those who cannot provide consent for the study 6. Known case of psychiatric disease

Design outcomes

Primary

MeasureTime frame
i. To assess the proportion of patients reaching the Hidradenitis Suppurativa Clinical Response (HiSCR) at the end of the study.Timepoint: 12 weeks.

Secondary

MeasureTime frame
i. To assess the proportion of patients reaching HiSCR at week 4. ii. To compare the clinical outcome in each group at the end of the study. iii. To compare the functional outcome in each group at the end of the study, as assessed by DLQI. To evaluate the safety profile of apremilast versus doxycycline in moderate HS.Timepoint: 12 weeks

Countries

India

Contacts

Public ContactDipankar De

Post Graduate Institute of Medical Education and Research, Chandigarh

dr_dipankar_de@yahoo.in0172-2756562

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026