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NCT Number: NCT07708480

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

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.

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Key information

Conditions

Hidradenitis Suppurativa Bacterial Infections Bacterial Infections and Mycoses Hidradenitis Infections Skin Diseases Skin Diseases, Bacterial Skin Diseases, Infectious Skin and Connective Tissue Diseases Suppuration Sweat Gland Diseases

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Medical Teaching Institution-Lady Reading Hospital

Peshawar, Khyber Pakhtunkhwa, 26000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Apremilast

Drug

Oral apremilast 30 mg administered twice daily for 12 weeks in participants with moderate-to-severe hidradenitis suppurativa

acitretin

Drug

Oral acitretin 25 mg administered twice daily for 12 weeks in participants with moderate-to-severe hidradenitis suppurativa

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Hayat Abad Medical Complex, Peshawar

Other Gov

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 16, 2026
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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