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Also known as Toctino
alitretinoin · 2 trials · 2 indications
The investigator assigned PGA grades according to a 5-point scale (clear \[not detectable\], almost clear \[less than 10% of affected hand surface\], mild disease \[less than 10% of affected hand surface\], moderate disease \[10% to 30% of affected hand surface\], severe disease \[\>30% of affected hand surface\]). PGA ratings were based on an integrated clinical picture of signs, symptoms, and the extent of disease. Symptoms included erythema, scaling, hyperkeratosis/lichenification, vesiculation, edema, fissures, and pruritus/pain. The PGA scale ranges from 0 (no symptom) to 4 (severe disease). Participants were considered as responders when they had a PGA of clear or almost clear.
The investigator evaluated the PPPASI score on a 5-point scale. The parameters of erythema, total number of pustules, and desquamation were scored for the right/left palm and the right/left sole. After correcting the scores for area (based on a 7-point scale) and the site involved (palm or sole), the PPPASI score per palm/sole was produced. The final PPPASI score was calculated as the sum of the PPPASI score for the right sole + the PPPASI score for the left sole + the PPPASI score for the right palm + the PPPASI score for the left palm and ranges from 0 (no palmo-plantar pustulosis psoriasis \[PPP\]) to 72 (most severe PPP). Change from Baseline is defined as value at the EOT minus the Baseline value.
The investigator evaluated the PPPASI score on a 5-point scale. The parameters of erythema, total number of pustules, and desquamation were scored for the right/left palm and the right/left sole. After correcting the scores for area (based on a 7-point scale) and the site involved (palm or sole), the PPPASI score per palm/sole was produced. The final PPPASI score was calculated as the sum of the PPPASI score for the right sole + the PPPASI score for the left sole + the PPPASI score for the right palm + the PPPASI score for the left palm and ranges from 0 (no palmo-plantar pustulosis psoriasis \[PPP\]) to 72 (most severe PPP). Change from Baseline is defined as value at the EOT minus the Baseline value. PPPASI 50 response and PPPASI 75 response are defined as a 50% and 75% decrease, respectively, in the PPPASI score from Baseline.
| Arm | Type | Description |
|---|---|---|
| Alitretinoin | EXPERIMENTAL | Patients will receive alitretinoin 30mg capsule for up to 24 weeks |
| Placebo | EXPERIMENTAL | Patients will receive placebo 30mg capsule for up to 24 weeks |
| Active | ACTIVE_COMPARATOR | to receive study drug (alitretinoin, 20 patients) |
| Name | Type | Description |
|---|---|---|
| alitretinoin | DRUG | Patients receive alitretinoin 30mg one capsule daily for up to 24 weeks |
| Placebo | DRUG | Patients receive matching placebo for up to 24 weeks |
Inclusion Criteria: * all types of chronic hand eczema, lasting for at least 6 months since initial diagnosis * rated as severe by the physician * unresponsive to highly potent topical corticosteroids, such as clobetasol Exclusion Criteria: * patients whose disease is adequately controlled by sta...
Alitretinoin is a small molecule retinoid developed by GSK plc for dermatologic conditions, specifically eczema and psoriasis. It is an agonist that binds retinoic acid receptors and retinoid X receptors. GSK is studying it in Phase 3 clinical development, with a completed Phase 3 trial in severe chronic hand eczema and a completed Phase 2 trial in pustular psoriasis.
Alitretinoin targets the retinoid X receptors RXRB, RXRG, and RXRA, along with the retinoic acid receptors RARB and RARA. It acts as an agonist at these nuclear receptors, which regulate gene expression involved in cell differentiation and proliferation. This receptor activity underlies its development as a retinoid therapy for inflammatory skin conditions such as eczema and psoriasis.
Alitretinoin is developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor of the clinical program evaluating the drug in dermatologic indications including eczema and psoriasis. The company holds the development rights for this small molecule retinoid agonist.
Alitretinoin is in Phase 3 clinical development. A Phase 3 trial in severe chronic hand eczema has been completed, and a Phase 2 trial in pustular psoriasis has also been completed. The drug is investigational and is not described as approved for any indication.
Alitretinoin has been studied in two completed trials. NCT00817063 was a Phase 3 trial evaluating efficacy and safety in severe chronic hand eczema, enrolling 599 patients in the United States. NCT01245140 was a Phase 2 trial testing alitretinoin in patients with the pustular form of psoriasis, enrolling 33 patients across France, Germany, the Netherlands, and the United Kingdom.
Alitretinoin has been evaluated for the treatment of severe chronic hand eczema. A completed Phase 3 trial, NCT00817063, assessed its efficacy and safety in adults with this condition. The study was randomized, double blind, and controlled, enrolling 599 participants. Alitretinoin remains in clinical development for eczema and is not described as approved.