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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07708480
Enrollment
70
Registered
2026-07-16
Start date
2024-12-22
Completion date
2025-05-22
Last updated
2026-07-16

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

Conditions

Hidradenitis Suppurativa

Keywords

Hidradenitis Suppurativa, Acne Inversa, Acitretin

Brief summary

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.

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.

Interventions

DRUGApremilast

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

DRUGAcitretin

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

Sponsors

Hayat Abad Medical Complex, Peshawar
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Participants were randomly assigned in a 1:1 ratio to one of two parallel treatment groups. Group A received oral apremilast 30 mg twice daily, and Group B received oral acitretin 25 mg twice daily for 12 weeks. Treatment outcomes were compared between the two groups.

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Treatment Efficacy12 weeksTreatment 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

MeasureTime frameDescription
Change in International Hidradenitis Suppurativa Severity Score System (IHS4) ScoreBaseline and 12 weeksComparison of mean IHS4 scores between the apremilast and acitretin treatment groups at baseline and after 12 weeks of therapy.

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 17, 2026