Comparative Efficacy of Apremilast and Acitretin in Moderate-to-Severe Hidradenitis Suppurativa

July 13, 2026 updated by: Huma Gul, Hayat Abad Medical Complex, Peshawar
This randomized controlled trial compares the efficacy of oral apremilast and oral acitretin in the treatment of moderate-to-severe hidradenitis suppurativa. Seventy eligible adults were randomly assigned to receive either apremilast (30 mg twice daily) or acitretin (25 mg twice daily) for 12 weeks. The primary outcome was improvement in disease severity measured using the International Hidradenitis Suppurativa Severity Score System (IHS4). The study aims to determine which treatment provides greater clinical improvement and may help guide treatment decisions for patients with moderate-to-severe hidradenitis suppurativa.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Hidradenitis suppurativa (HS) is a chronic inflammatory skin disease characterized by recurrent painful nodules, abscesses, sinus tracts, and scarring, resulting in considerable impairment in quality of life. Although several systemic therapies are available, evidence directly comparing oral non-biologic treatment options remains limited.

This investigator-initiated, single-center, randomized controlled trial was conducted at the Department of Dermatology, Medical Teaching Institution-Hayatabad Medical Complex, Peshawar, Pakistan. Seventy adults aged 18 to 40 years with clinically diagnosed moderate-to-severe hidradenitis suppurativa were enrolled and randomly allocated in a 1:1 ratio to receive either oral apremilast 30 mg twice daily or oral acitretin 25 mg twice daily for 12 weeks.

Disease severity was assessed using the International Hidradenitis Suppurativa Severity Score System (IHS4). The primary efficacy endpoint was a reduction of at least five points in the IHS4 score from baseline after 12 weeks of treatment. Secondary assessments included comparison of mean IHS4 scores at the end of treatment and evaluation of treatment response according to demographic characteristics.

The study was approved by the Institutional Research and Ethical Review Board of Medical Teaching Institution-Hayatabad Medical Complex, Peshawar (Approval No. 1772), and written informed consent was obtained from all participants before enrollment. Data were analyzed using standard statistical methods with statistical significance defined as a two-sided p-value of 0.05 or less. The results are expected to provide comparative evidence regarding the effectiveness of apremilast and acitretin for the management of moderate-to-severe hidradenitis suppurativa and to inform future clinical practice and research.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Khyber Pakhtunkhwa
      • Peshawar, Khyber Pakhtunkhwa, Pakistan, 26000
        • Medical Teaching Institution-Lady Reading Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults aged 18 to 40 years.
  • Clinically diagnosed moderate hidradenitis suppurativa (International
  • Hidradenitis Suppurativa Severity Score System [IHS4] score 4-10) or severe hidradenitis suppurativa (IHS4 score ≥11).
  • Able and willing to provide written informed consent.
  • Willing to comply with study visits and treatment for 12 weeks.

Exclusion Criteria:

  • Pregnancy.
  • Previous severe hypersensitivity or adverse reaction to apremilast or acitretin.
  • Refusal or inability to provide written informed consent.
  • Diabetes mellitus.
  • Severe depression.
  • Dyslipidemia.
  • Severe hepatic impairment.
  • Severe renal impairment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Oral Apremilast Treatment
Participants received oral apremilast 30 mg twice daily for 12 weeks.
Drug: Apremilast
Oral apremilast 30 mg administered twice daily for 12 weeks in participants with moderate-to-severe hidradenitis suppurativa
Active Comparator: Oral Acitretin Treatment
Participants received oral acitretin 25 mg twice daily for 12 weeks.
Drug: Acitretin
Oral acitretin 25 mg administered twice daily for 12 weeks in participants with moderate-to-severe hidradenitis suppurativa

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment Efficacy
Time Frame: 12 weeks
Treatment efficacy will be assessed as the proportion of participants achieving a reduction of at least 5 points from baseline in the International Hidradenitis Suppurativa Severity Score System (IHS4) after 12 weeks of treatment.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in International Hidradenitis Suppurativa Severity Score System (IHS4) Score
Time Frame: Baseline and 12 weeks
Comparison of mean IHS4 scores between the apremilast and acitretin treatment groups at baseline and after 12 weeks of therapy.
Baseline and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hayat Abad Medical Complex, Peshawar

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 22, 2024

Primary Completion (Actual)

May 22, 2025

Study Completion (Actual)

May 22, 2025

Study Registration Dates

First Submitted

July 13, 2026

First Submitted That Met QC Criteria

July 13, 2026

First Posted (Actual)

July 16, 2026

Study Record Updates

Last Update Posted (Actual)

July 16, 2026

Last Update Submitted That Met QC Criteria

July 13, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PSP-REU-DER-2023-021-19362
  • CPSP/REU/DER-2023-021-19362 (Other Identifier: Institutional Research and Ethical Review Board, Hayatabad Medical Complex.)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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