Dermal sensitization, safety, tolerability, and patient preference of tazarotene 0.045% lotion from five clinical trials
Background Topical retinoids are recommended for acne treatment, but their use may be limited by irritation or dermatitis. Herein is an overview of the dermal sensitization, safety, tolerability, and participant satisfaction data from phase-1, -2, and -3 studies of lower-dose tazarotene 0.045% polym...
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| Format: | Article |
| Language: | English |
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Taylor & Francis Group
2022-05-01
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| Series: | Journal of Dermatological Treatment |
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| Online Access: | http://dx.doi.org/10.1080/09546634.2021.1944969 |
| _version_ | 1797683495074529280 |
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| author | Leon H. Kircik Lawrence Green Eric Guenin Waleed Khalid Binu Alexander |
| author_facet | Leon H. Kircik Lawrence Green Eric Guenin Waleed Khalid Binu Alexander |
| author_sort | Leon H. Kircik |
| collection | DOAJ |
| description | Background Topical retinoids are recommended for acne treatment, but their use may be limited by irritation or dermatitis. Herein is an overview of the dermal sensitization, safety, tolerability, and participant satisfaction data from phase-1, -2, and -3 studies of lower-dose tazarotene 0.045% polymeric emulsion lotion. Methods Two phase-1, single-blind, vehicle-controlled dermal safety studies were conducted in healthy participants aged ≥18 years. One phase-2 (NCT02938494) and two phase-3 studies (NCT03168334; NCT03168321) were double-blind, randomized, and vehicle-controlled over 12 weeks in participants aged ≥9 years (≥12 years, phase-2) with moderate-to-severe acne. Results A total of 2029 participants (tazarotene 0.045% lotion or vehicle) were included across the 5 studies (safety populations: n = 1982). In the phase-1 studies, tazarotene had a low potential for irritancy/contact dermatitis and did not induce sensitization. In all studies, tazarotene lotion was well tolerated and had a positive safety profile. In addition, tazarotene lotion reduced the severity of hyperpigmentation and erythema and participants preferred it more than previous acne treatments. Conclusions The results from these five studies show that the tolerability, safety, and patient satisfaction of topical tazarotene 0.045% lotion, combined with its efficacy, make it an important option for the treatment of acne. |
| first_indexed | 2024-03-12T00:16:16Z |
| format | Article |
| id | doaj.art-bd2379cc459943999833f7f9fe5701e6 |
| institution | Directory Open Access Journal |
| issn | 0954-6634 1471-1753 |
| language | English |
| last_indexed | 2024-03-12T00:16:16Z |
| publishDate | 2022-05-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Journal of Dermatological Treatment |
| spelling | doaj.art-bd2379cc459943999833f7f9fe5701e62023-09-15T14:28:51ZengTaylor & Francis GroupJournal of Dermatological Treatment0954-66341471-17532022-05-013342241224910.1080/09546634.2021.19449691944969Dermal sensitization, safety, tolerability, and patient preference of tazarotene 0.045% lotion from five clinical trialsLeon H. Kircik0Lawrence Green1Eric Guenin2Waleed Khalid3Binu Alexander4School of Medicine, Indiana UniversityDepartment of Dermatology, George Washington University School of MedicineOrtho Dermatologics, Bausch Health US, LLCBausch Health US, LLCBausch Health US, LLCBackground Topical retinoids are recommended for acne treatment, but their use may be limited by irritation or dermatitis. Herein is an overview of the dermal sensitization, safety, tolerability, and participant satisfaction data from phase-1, -2, and -3 studies of lower-dose tazarotene 0.045% polymeric emulsion lotion. Methods Two phase-1, single-blind, vehicle-controlled dermal safety studies were conducted in healthy participants aged ≥18 years. One phase-2 (NCT02938494) and two phase-3 studies (NCT03168334; NCT03168321) were double-blind, randomized, and vehicle-controlled over 12 weeks in participants aged ≥9 years (≥12 years, phase-2) with moderate-to-severe acne. Results A total of 2029 participants (tazarotene 0.045% lotion or vehicle) were included across the 5 studies (safety populations: n = 1982). In the phase-1 studies, tazarotene had a low potential for irritancy/contact dermatitis and did not induce sensitization. In all studies, tazarotene lotion was well tolerated and had a positive safety profile. In addition, tazarotene lotion reduced the severity of hyperpigmentation and erythema and participants preferred it more than previous acne treatments. Conclusions The results from these five studies show that the tolerability, safety, and patient satisfaction of topical tazarotene 0.045% lotion, combined with its efficacy, make it an important option for the treatment of acne.http://dx.doi.org/10.1080/09546634.2021.1944969topicalretinoidtazarotenesafety |
| spellingShingle | Leon H. Kircik Lawrence Green Eric Guenin Waleed Khalid Binu Alexander Dermal sensitization, safety, tolerability, and patient preference of tazarotene 0.045% lotion from five clinical trials Journal of Dermatological Treatment topical retinoid tazarotene safety |
| title | Dermal sensitization, safety, tolerability, and patient preference of tazarotene 0.045% lotion from five clinical trials |
| title_full | Dermal sensitization, safety, tolerability, and patient preference of tazarotene 0.045% lotion from five clinical trials |
| title_fullStr | Dermal sensitization, safety, tolerability, and patient preference of tazarotene 0.045% lotion from five clinical trials |
| title_full_unstemmed | Dermal sensitization, safety, tolerability, and patient preference of tazarotene 0.045% lotion from five clinical trials |
| title_short | Dermal sensitization, safety, tolerability, and patient preference of tazarotene 0.045% lotion from five clinical trials |
| title_sort | dermal sensitization safety tolerability and patient preference of tazarotene 0 045 lotion from five clinical trials |
| topic | topical retinoid tazarotene safety |
| url | http://dx.doi.org/10.1080/09546634.2021.1944969 |
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