- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07708480
Comparative Efficacy of Apremilast and Acitretin in Moderate-to-Severe Hidradenitis Suppurativa
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 4
Kontakter og lokationer
Studiesteder
-
-
Khyber Pakhtunkhwa
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Peshawar, Khyber Pakhtunkhwa, Pakistan, 26000
- Medical Teaching Institution-Lady Reading Hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Oral Apremilast Treatment
Participants received oral apremilast 30 mg twice daily for 12 weeks.
|
Oral apremilast 30 mg administered twice daily for 12 weeks in participants with moderate-to-severe hidradenitis suppurativa
|
|
Aktiv komparator: Oral Acitretin Treatment
Participants received oral acitretin 25 mg twice daily for 12 weeks.
|
Oral acitretin 25 mg administered twice daily for 12 weeks in participants with moderate-to-severe hidradenitis suppurativa
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Treatment Efficacy
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in International Hidradenitis Suppurativa Severity Score System (IHS4) Score
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Infektioner
- Hudsygdomme
- Bakterielle infektioner
- Bakterielle infektioner og mykoser
- Svedkirtelsygdomme
- Hudsygdomme, bakteriel
- Hudsygdomme, smitsom
- Suppuration
- Hidradenitis
- Hud- og bindevævssygdomme
- Hidradenitis Suppurativa
- Organiske kemikalier
- Retinoider
- Carotenoider
- Polyener
- Alkener
- Kulbrinter, acyklisk
- Kulbrinter
- Terpenes
- Pigmenter, biologisk
- Biologiske faktorer
- Acitretin
- Apremilast
Andre undersøgelses-id-numre
- PSP-REU-DER-2023-021-19362
- CPSP/REU/DER-2023-021-19362 (Anden identifikator: Institutional Research and Ethical Review Board, Hayatabad Medical Complex.)
Plan for individuelle deltagerdata (IPD)
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Kliniske forsøg med Hidradenitis Suppurativa
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Julia Tatjana MaulUniversity of Zurich; University Hospital, ZürichRekrutteringHidradenitis Suppurativa (HS) | Hidradenitis Suppurativa (Acne Inversa)Schweiz
-
Peking Union Medical CollegeIkke rekrutterer endnuHidradenitis Suppurativa (HS) | Secukinumab | Hidradenitis Suppurativa (Acne Inversa)Kina
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Peking Union Medical CollegeRekrutteringHidradenitis Suppurativa (HS) | Secukinumab | Hidradenitis Suppurativa (Acne Inversa)Kina
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Harrison DermatologyIkke rekrutterer endnuHidradenitis Suppurativa (HS)Forenede Stater
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Thomas Jefferson UniversityRekrutteringHidradenitis Suppurativa (HS)Forenede Stater
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Navigator Medicines, Inc.RekrutteringHidradenitis Suppurativa (HS)Forenede Stater
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PeriPharmIkke rekrutterer endnuHidradenitis Suppurativa (HS)
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Rutgers, The State University of New JerseyRekruttering
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Sinocelltech Ltd.RekrutteringHidradenitis Suppurativa (HS)Tyrkiet (Türkiye)
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Bluefin Biomedicine, Inc.RekrutteringHidradenitis Suppurativa (HS)Spanien, Forenede Stater, Bulgarien, Canada, Tyskland, Polen, Tjekkiet
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