Hidradenitis SuppurativaPhase 4NCT07708480
Comparative Efficacy of Apremilast and Acitretin in Moderate-to-Severe Hidradenitis Suppurativa
A Phase 4 study testing Apremilast and Acitretin in people with Hidradenitis Suppurativa, run by Hayat Abad Medical Complex, Peshawar at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Hidradenitis Suppurativa
- What is being tested?
- Apremilast and Acitretin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 sitePakistan
- Study dates
- 22 Dec 2024to 22 May 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Medical Teaching Institution-Lady Reading Hospital
Peshawar, Khyber Pakhtunkhwa, 26000
About this study
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.
Read the 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.
- Conditions
- Hidradenitis Suppurativa
- Being tested
- Apremilast, Acitretin
- Keywords
- Hidradenitis Suppurativa, Acne Inversa, Acitretin
- Medical subject headings
- Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApremilastDrug
Oral apremilast 30 mg administered twice daily for 12 weeks in participants with moderate-to-severe hidradenitis suppurativa
AcitretinDrug
Oral acitretin 25 mg administered twice daily for 12 weeks in participants with moderate-to-severe hidradenitis suppurativa
| Study group | Role | What they receive |
|---|---|---|
| Oral Apremilast Treatment | Experimental | Participants received oral apremilast 30 mg twice daily for 12 weeks. Receives: Drug: Apremilast |
| Oral Acitretin Treatment | Active comparator | Participants received oral acitretin 25 mg twice daily for 12 weeks. Receives: Drug: Acitretin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (1)
Change in International Hidradenitis Suppurativa Severity Score System (IHS4) Score
Comparison of mean IHS4 scores between the apremilast and acitretin treatment groups at baseline and after 12 weeks of therapy.
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start22 Dec 2024
- Primary completion22 May 2025
- Study completion22 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hidradenitis SuppurativaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hayat Abad Medical Complex, Peshawar
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Huma Gul, Hayat Abad Medical Complex, Peshawar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07708480
- Sponsor's protocol ID
- PSP-REU-DER-2023-021-19362
- Other IDs
- CPSP/REU/DER-2023-021-19362
- Status last verified
- Jul 2026
- First submitted
- 13 Jul 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy of Apremilast and Acitretin in Moderate-to-Severe Hidradenitis Suppurativa
- ClinicalTrials.gov ID
- NCT07708480
- Acronym / sponsor ID
- PSP-REU-DER-2023-021-19362
- Conditions
- Hidradenitis Suppurativa
- Keywords
- Hidradenitis Suppurativa, Acne Inversa, Acitretin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Hayat Abad Medical Complex, PeshawarOther government
- Study start
- 22 Dec 2024 (actual)
- Primary completion
- 22 May 2025 (actual)
- Study completion
- 22 May 2025 (actual)
- First posted
- 16 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Oral Apremilast Treatment | Experimental | Drug: ApremilastParticipants received oral apremilast 30 mg twice daily for 12 weeks. |
| Oral Acitretin Treatment | Active comparator | Drug: AcitretinParticipants received oral acitretin 25 mg twice daily for 12 weeks. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- Pregnancy.
- Previous severe hypersensitivity or adverse reaction to apremilast or acitretin.
- Refusal or inability to provide written informed consent.
- Diabetes mellitus.
- Severe depression.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ApremilastOral apremilast 30 mg administered twice daily for 12 weeks in participants with moderate-to-severe hidradenitis suppurativa | Drug | Oral Apremilast Treatment |
| AcitretinOral acitretin 25 mg administered twice daily for 12 weeks in participants with moderate-to-severe hidradenitis suppurativa | Drug | Oral Acitretin Treatment |
Primary outcome
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.
1 secondary outcome
Change in International Hidradenitis Suppurativa Severity Score System (IHS4) Score
Time frame: Baseline and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Apremilast and Acitretin in people with Hidradenitis Suppurativa, run by Hayat Abad Medical Complex, Peshawar at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Efficacy (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.