Contact Sensitization and Phototoxic and Photoallergic Potential of Tirbanibulin 1% Ointment in Healthy Volunteers
Tirbanibulin 1% ointment is approved for the topical treatment of actinic keratosis, applied once daily for 5 days. Three phase 1 randomized, single-center, controlled, within-subject comparison studies were conducted to evaluate the sensitization (KX01-AK-006), phototoxic (KX01-AK-008), and photoal...
| Main Authors: | , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Elsevier
2023-03-01
|
| Series: | JID Innovations |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2667026722000789 |
| _version_ | 1797856445138468864 |
|---|---|
| author | Jonathan Dosik David L. Cutler Jane Fang Laura Padullés |
| author_facet | Jonathan Dosik David L. Cutler Jane Fang Laura Padullés |
| author_sort | Jonathan Dosik |
| collection | DOAJ |
| description | Tirbanibulin 1% ointment is approved for the topical treatment of actinic keratosis, applied once daily for 5 days. Three phase 1 randomized, single-center, controlled, within-subject comparison studies were conducted to evaluate the sensitization (KX01-AK-006), phototoxic (KX01-AK-008), and photoallergic (KX01-AK-009) potential of tirbanibulin 1% ointment in healthy adults. In KX01-AK-006 and KX01-AK-009, subjects received repeated applications of tirbanibulin or vehicle for induction (followed by irradiation in KX01-AK-009) and an additional application for the challenge on naïve sites. In KX01-AK-008, subjects received single applications, followed by irradiation. Sensitization was defined as a reaction scoring 3 at naïve sites, recurring at rechallenge. Photoallergy was assessed based on the dermal response of erythema + edema at naïve sites. Phototoxicity was assessed based on the average dermal response score (days 3‒4). Adverse events were collected. In KX01-AK-006, none of the 229 subjects scored 3 at naïve sites. In KX01-AK-008, none of the 31 subjects developed edema, not meeting the criteria for phototoxicity. In KX01-AK-009, none of the 59 subjects showed reactions compatible with photoallergy. Mild-to-moderate contact irritations were reported. The evidence provided by these phase 1 studies showed that tirbanibulin 1% ointment lacks sensitization and phototoxic or photoallergic potential, and supports the safety of its topical application. |
| first_indexed | 2024-04-09T20:40:34Z |
| format | Article |
| id | doaj.art-d204ed72a1a54b1cae02746f5eb630bc |
| institution | Directory Open Access Journal |
| issn | 2667-0267 |
| language | English |
| last_indexed | 2024-04-09T20:40:34Z |
| publishDate | 2023-03-01 |
| publisher | Elsevier |
| record_format | Article |
| series | JID Innovations |
| spelling | doaj.art-d204ed72a1a54b1cae02746f5eb630bc2023-03-30T04:27:19ZengElsevierJID Innovations2667-02672023-03-0132100170Contact Sensitization and Phototoxic and Photoallergic Potential of Tirbanibulin 1% Ointment in Healthy VolunteersJonathan Dosik0David L. Cutler1Jane Fang2Laura Padullés3TKL Research, Fair Lawn, New Jersey, USA; Correspondence: Jonathan Dosik, TKL Research, One Promenade Boulevard, Suite 1201, Fair Lawn, New Jersey 07410, USA.Athenex, Buffalo, New York, USAAthenex, Buffalo, New York, USAAlmirall, Barcelona, SpainTirbanibulin 1% ointment is approved for the topical treatment of actinic keratosis, applied once daily for 5 days. Three phase 1 randomized, single-center, controlled, within-subject comparison studies were conducted to evaluate the sensitization (KX01-AK-006), phototoxic (KX01-AK-008), and photoallergic (KX01-AK-009) potential of tirbanibulin 1% ointment in healthy adults. In KX01-AK-006 and KX01-AK-009, subjects received repeated applications of tirbanibulin or vehicle for induction (followed by irradiation in KX01-AK-009) and an additional application for the challenge on naïve sites. In KX01-AK-008, subjects received single applications, followed by irradiation. Sensitization was defined as a reaction scoring 3 at naïve sites, recurring at rechallenge. Photoallergy was assessed based on the dermal response of erythema + edema at naïve sites. Phototoxicity was assessed based on the average dermal response score (days 3‒4). Adverse events were collected. In KX01-AK-006, none of the 229 subjects scored 3 at naïve sites. In KX01-AK-008, none of the 31 subjects developed edema, not meeting the criteria for phototoxicity. In KX01-AK-009, none of the 59 subjects showed reactions compatible with photoallergy. Mild-to-moderate contact irritations were reported. The evidence provided by these phase 1 studies showed that tirbanibulin 1% ointment lacks sensitization and phototoxic or photoallergic potential, and supports the safety of its topical application.http://www.sciencedirect.com/science/article/pii/S2667026722000789 |
| spellingShingle | Jonathan Dosik David L. Cutler Jane Fang Laura Padullés Contact Sensitization and Phototoxic and Photoallergic Potential of Tirbanibulin 1% Ointment in Healthy Volunteers JID Innovations |
| title | Contact Sensitization and Phototoxic and Photoallergic Potential of Tirbanibulin 1% Ointment in Healthy Volunteers |
| title_full | Contact Sensitization and Phototoxic and Photoallergic Potential of Tirbanibulin 1% Ointment in Healthy Volunteers |
| title_fullStr | Contact Sensitization and Phototoxic and Photoallergic Potential of Tirbanibulin 1% Ointment in Healthy Volunteers |
| title_full_unstemmed | Contact Sensitization and Phototoxic and Photoallergic Potential of Tirbanibulin 1% Ointment in Healthy Volunteers |
| title_short | Contact Sensitization and Phototoxic and Photoallergic Potential of Tirbanibulin 1% Ointment in Healthy Volunteers |
| title_sort | contact sensitization and phototoxic and photoallergic potential of tirbanibulin 1 ointment in healthy volunteers |
| url | http://www.sciencedirect.com/science/article/pii/S2667026722000789 |
| work_keys_str_mv | AT jonathandosik contactsensitizationandphototoxicandphotoallergicpotentialoftirbanibulin1ointmentinhealthyvolunteers AT davidlcutler contactsensitizationandphototoxicandphotoallergicpotentialoftirbanibulin1ointmentinhealthyvolunteers AT janefang contactsensitizationandphototoxicandphotoallergicpotentialoftirbanibulin1ointmentinhealthyvolunteers AT laurapadulles contactsensitizationandphototoxicandphotoallergicpotentialoftirbanibulin1ointmentinhealthyvolunteers |