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

NCT07708480 | Completed Phase 4

• 2 other identifiers: PSP-REU-DER-2023-021-19362CPSP/REU/DER-2023-021-19362
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Hidradenitis Suppurativa

Keywords

Hidradenitis Suppurativa; Acne Inversa; Acitretin

Outcome Measures

Primary Outcomes (1)

• Treatment Efficacy

  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 Outcomes (1)

• Change in International Hidradenitis Suppurativa Severity Score System (IHS4) Score

  Baseline and 12 weeks

Study Arms (2)

Oral Apremilast Treatment

EXPERIMENTAL

Participants received oral apremilast 30 mg twice daily for 12 weeks.

Drug: Apremilast

Oral Acitretin Treatment

ACTIVE COMPARATOR

Participants received oral acitretin 25 mg twice daily for 12 weeks.

Drug: Acitretin

Interventions

Apremilast DRUG

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

Oral Apremilast Treatment

Acitretin DRUG

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

Oral Acitretin Treatment

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hayat Abad Medical Complex, Peshawar: lead

Study Sites (1)

Medical Teaching Institution-Lady Reading Hospital

Peshawar, Khyber Pakhtunkhwa, 26000, Pakistan

Location

MeSH Terms

Conditions

Hidradenitis Suppurativa

Interventions

apremilast; Acitretin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Terpenes; Pigments, Biological; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PGR

Model Details: 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.

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: July 16, 2026
• Study Start: December 22, 2024
• Primary Completion: May 22, 2025
• Study Completion: May 22, 2025
• Last Updated: July 16, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)