Peloton Advantage, LLC, an OPEN Health company, and was funded by Pfizer Consumer Healthcare. On August 1, 2019, Pfizer Consumer Healthcare became part of GSK Consumer Healthcare.
Data Sharing Statement: Upon request, and subject to certain criteria, conditions and exceptions (see https://www.pfizer. com/science/clinical-trials/trial-data-and-results for more information), Pfizer will provide access to individual de-identified participant data from Pfizer-sponsored global interventional clinical studies conducted for medicines, vaccines and medical devices (1) for indications that have been approved in the US and/or EU or (2) in programs that have been terminated (ie, development for all indications has been discontinued). Pfizer will also consider requests for the protocol, data dictionary, and statistical analysis plan. Data may be requested from Pfizer trials 24 months after study completion. The de-identified participant data will be made available to researchers whose proposals meet the research criteria and other conditions, and for which an exception does not apply, via a secure portal. To gain access, data requestors must enter into a data access agreement with Pfizer. On August 1, 2019, Pfizer Consumer Healthcare became part of GSK Consumer Healthcare.
Data Sharing Statement: Upon request, and subject to certain criteria, conditions and exceptions (see https://www.pfizer. com/science/clinical-trials/trial-data-and-results for more information), Pfizer will provide access to individual de-identified participant data from Pfizer-sponsored global interventional clinical studies conducted for medicines, vaccines and medical devices (1) for indications that have been approved in the US and/or EU or (2) in programs that have been terminated (ie, development for all indications has been discontinued). Pfizer will also consider requests for the protocol, data dictionary, and statistical analysis plan. Data may be requested from Pfizer trials 24 months after study completion. The de-identified participant data will be made available to researchers whose proposals meet the research criteria and other conditions, and for which an exception does not apply, via a secure portal. To gain access, data requestors must enter into a data access agreement with Pfizer. On August 1, 2019, Pfizer Consumer Healthcare became part of GSK Consumer Healthcare.
REFERENCES
1. Park H, Kayser C, Thut G, Gross J. Lip movements entrain the observers' low-frequency brain oscillations to facilitate speech intelligibility. eLife. 2016;5.
2. Warren DW, Drake AF, Davis JU. Nasal airway in breathing and speech. Cleft Palate Craniofac J. 1992;29(6):511-519.
3. Piccinin MA, Zito PM. Anatomy, Head and Neck, Lips. StatPearls. Treasure Island, FL: StatPearls Publishing. 2019.
4. Cancer Registration & Surveillance Modules. Mouth. National Cancer Institute Surveillance, Epidemiology, and End Results Training Modules, 2019. Available at: https://training.seer.cancer.gov/anatomy/digestive/regions/ mouth.html. Accessed March 27, 2020.
5. Kar M, Muluk NB, Bafaqeeh SA, Cingi C. Is it possible to define the ideal lips? Acta Otorhinolaryngol Ital. 2018;38(1):67-72.
6. Vo ML, Smith TJ, Mital PK, Henderson JM. Do the eyes really have it? Dynamic allocation of attention when viewing moving faces. J VIs. 2012;12(13).
7. Peterson MF, Eckstein MP. Looking just below the eyes is optimal across face recognition tasks. Proc Natl Acad Sci U S A. 2012;109(48):E3314-3323.
8. Tagami H. Location-related differences in structure and function of the stratum corneum with special emphasis on those of the facial skin. Int J Cosmet Sci. 2008;30(6):413-434.
9. Boer M, Duchnik E, Maleszka R, Marchlewicz M. Structural and biophysical characteristics of human skin in maintaining proper epidermal barrier function. Postepy Dermatol Alergol. 2016;33(1):1-5.
10. Layers in the epidermis. University of Leeds, 2003. Available at: https:// www.histology.leeds.ac.uk/skin/epidermis_layers.php. Accessed March 27, 2020.
11. Keratins. National Institutes of Health, 2019. Available at: https://ghr.nlm.nih. gov/primer/genefamily/keratins. Accessed March 27, 2020.
12. Trookman NS, Rizer RL, Ford R, et al. Clinical assessment of a combination lip treatment to restore moisturization and fullness. J Clin Aesthet Dermatol. 2009;2(12):44-48.
13. Tamura E, Ishikawa J, Naoe A, Yamamoto T. The roughness of lip skin is related to the ceramide profile in the stratum corneum. Int J Cosmet Sci. 2016;38(6):615-621.
14. Gfeller CF, Wanser R, Mahalingam H, et al. A series of in vitro and human studies of a novel lip cream formulation for protecting against environmental triggers of recurrent herpes labialis. Clin Cosmet Investig Dermatol. 2019;12:193-208.
15. Lugovic-Mihic L, Pilipovic K, Crnaric I, et al. Differential diagnosis of cheilitis - How to classify cheilitis? Acta Clin Croat. 2018;57(2):342-351.
16. Rossi AB, Nkengne A, Stamatas G, Bertin C. Development and validation of a photonumeric grading scale for assessing lip volume and thickness. J Eur Acad Dermatol Venereol. 2011;25(5):523-531.
17. Griffiths CE, Wang TS, Hamilton TA, et al. A photonumeric scale for the assessment of cutaneous photodamage. Arch Dermatol. 1992;128(3):347-351.
18. Ayer J, Ahmed A, Duncan-Parry E, et al. A photonumeric scale for the assessment of atrophic facial photodamage. Br J Dermatol. 2018;178(5):1190- 1195.
19. Werschler WP, Fagien S, Thomas J, et al. Development and validation of a photographic scale for assessment of lip fullness. Aesthet Surg J. 2015;35(3):294-307.
20. Carruthers A, Carruthers J, Hardas B, et al. A validated lip fullness grading scale. Dermatol Surg. 2008;34 Suppl 2:S161-166.
21. Shin JW, Kwon SH, Choi JY, et al. Molecular mechanisms of dermal aging and antiaging approaches. Int J Mol Sci. 2019;20(9).
22. Wambier CG, Neitzke IC, Lee KC, et al. Augmentation and eversion of lips without injections: The lip peel. J Am Acad Dermatol. 2019;80(5):e119-e120.
23. Lip enhancement options. American Board of Cosmetic Surgery, 2019. Available at: https://www.americanboardcosmeticsurgery.org/procedure-learning- center/facial-procedures/lip-enhancement/. Accessed March 27, 2020.
24. Salibian AA, Bluebond-Langner R. Lip lift. Facial Plast Surg Clin North Am. 2019;27(2):261-266.
25. Montagna W, Prota G, Kenney JA Jr. Biological differences between blacks and whites. In: Montagna W, Prota G, Kenney JA, Jr., eds. Black Skin Structure and Function. London, United Kingdom: Academic Press; 1993:55-60.
26. Goldsberry A, Hanke CW, Hanke KE. VISIA system: a possible tool in the cosmetic practice. J Drugs Dermatol. 2014;13(11):1312-1314.
27. Czerninski R, Lederman D, Ephros H, Kerr R. Solar cheilitis. American Academy of Oral Medicine, 2008. Available at: https://maaom.memberclicks. net/index.php?option=com_content&view=article&id=137: solar-cheilitis&catid=22:patient-condition-information&Itemid=120. Accessed March 27, 2020.
28. Poitevin NA, Rodrigues SR, Weigert KL, et al. Actinic cheilitis: proposition and reproducibility of a clinical criterion. BDJOpen. 2017;3:17016.
29. Buchner L, Vamvakias G, Rom D. Validation of a photonumeric wrinkle assessment scale for assessing nasolabial fold wrinkles. Plast Reconstr Surg. 2010;126(2):596-601.
30. Carruthers J, Jones D, Hardas B, et al. Development and validation of a photonumeric scale for evaluation of volume deficit of the temple. Dermatol Surg. 2016;42(Suppl 1):S203-S210.
31. Niforos F, Liew S, Acquilla R, et al. Creation and validation of a photonumeric scale to assess volume deficiency in the infraorbital region. Dermatol Surg. 2017;43(5):684-691.
32. Farage MA, Miller KW, Elsner P, Maibach HI. Intrinsic and extrinsic factors in skin ageing: a review. Int J Cosmet Sci. 2008;30(2):87-95.
33. Rodriguez-Blanco I, Florez A, Paredes-Suarez C, et al. Use of lip photoprotection in patients suffering from actinic cheilitis. Eur J Dermatol. 2019;29(4):383-386.
34. Draelos ZD. New treatments for restoring impaired epidermal barrier permeability: skin barrier repair creams. Clin Dermatol. 2012;30(3):345-348.
35. Verdier-Sevrain S, Bonte F. Skin hydration: a review on its molecular mechanisms. J Cosmet Dermatol. 2007;6(2):75-82.
2. Warren DW, Drake AF, Davis JU. Nasal airway in breathing and speech. Cleft Palate Craniofac J. 1992;29(6):511-519.
3. Piccinin MA, Zito PM. Anatomy, Head and Neck, Lips. StatPearls. Treasure Island, FL: StatPearls Publishing. 2019.
4. Cancer Registration & Surveillance Modules. Mouth. National Cancer Institute Surveillance, Epidemiology, and End Results Training Modules, 2019. Available at: https://training.seer.cancer.gov/anatomy/digestive/regions/ mouth.html. Accessed March 27, 2020.
5. Kar M, Muluk NB, Bafaqeeh SA, Cingi C. Is it possible to define the ideal lips? Acta Otorhinolaryngol Ital. 2018;38(1):67-72.
6. Vo ML, Smith TJ, Mital PK, Henderson JM. Do the eyes really have it? Dynamic allocation of attention when viewing moving faces. J VIs. 2012;12(13).
7. Peterson MF, Eckstein MP. Looking just below the eyes is optimal across face recognition tasks. Proc Natl Acad Sci U S A. 2012;109(48):E3314-3323.
8. Tagami H. Location-related differences in structure and function of the stratum corneum with special emphasis on those of the facial skin. Int J Cosmet Sci. 2008;30(6):413-434.
9. Boer M, Duchnik E, Maleszka R, Marchlewicz M. Structural and biophysical characteristics of human skin in maintaining proper epidermal barrier function. Postepy Dermatol Alergol. 2016;33(1):1-5.
10. Layers in the epidermis. University of Leeds, 2003. Available at: https:// www.histology.leeds.ac.uk/skin/epidermis_layers.php. Accessed March 27, 2020.
11. Keratins. National Institutes of Health, 2019. Available at: https://ghr.nlm.nih. gov/primer/genefamily/keratins. Accessed March 27, 2020.
12. Trookman NS, Rizer RL, Ford R, et al. Clinical assessment of a combination lip treatment to restore moisturization and fullness. J Clin Aesthet Dermatol. 2009;2(12):44-48.
13. Tamura E, Ishikawa J, Naoe A, Yamamoto T. The roughness of lip skin is related to the ceramide profile in the stratum corneum. Int J Cosmet Sci. 2016;38(6):615-621.
14. Gfeller CF, Wanser R, Mahalingam H, et al. A series of in vitro and human studies of a novel lip cream formulation for protecting against environmental triggers of recurrent herpes labialis. Clin Cosmet Investig Dermatol. 2019;12:193-208.
15. Lugovic-Mihic L, Pilipovic K, Crnaric I, et al. Differential diagnosis of cheilitis - How to classify cheilitis? Acta Clin Croat. 2018;57(2):342-351.
16. Rossi AB, Nkengne A, Stamatas G, Bertin C. Development and validation of a photonumeric grading scale for assessing lip volume and thickness. J Eur Acad Dermatol Venereol. 2011;25(5):523-531.
17. Griffiths CE, Wang TS, Hamilton TA, et al. A photonumeric scale for the assessment of cutaneous photodamage. Arch Dermatol. 1992;128(3):347-351.
18. Ayer J, Ahmed A, Duncan-Parry E, et al. A photonumeric scale for the assessment of atrophic facial photodamage. Br J Dermatol. 2018;178(5):1190- 1195.
19. Werschler WP, Fagien S, Thomas J, et al. Development and validation of a photographic scale for assessment of lip fullness. Aesthet Surg J. 2015;35(3):294-307.
20. Carruthers A, Carruthers J, Hardas B, et al. A validated lip fullness grading scale. Dermatol Surg. 2008;34 Suppl 2:S161-166.
21. Shin JW, Kwon SH, Choi JY, et al. Molecular mechanisms of dermal aging and antiaging approaches. Int J Mol Sci. 2019;20(9).
22. Wambier CG, Neitzke IC, Lee KC, et al. Augmentation and eversion of lips without injections: The lip peel. J Am Acad Dermatol. 2019;80(5):e119-e120.
23. Lip enhancement options. American Board of Cosmetic Surgery, 2019. Available at: https://www.americanboardcosmeticsurgery.org/procedure-learning- center/facial-procedures/lip-enhancement/. Accessed March 27, 2020.
24. Salibian AA, Bluebond-Langner R. Lip lift. Facial Plast Surg Clin North Am. 2019;27(2):261-266.
25. Montagna W, Prota G, Kenney JA Jr. Biological differences between blacks and whites. In: Montagna W, Prota G, Kenney JA, Jr., eds. Black Skin Structure and Function. London, United Kingdom: Academic Press; 1993:55-60.
26. Goldsberry A, Hanke CW, Hanke KE. VISIA system: a possible tool in the cosmetic practice. J Drugs Dermatol. 2014;13(11):1312-1314.
27. Czerninski R, Lederman D, Ephros H, Kerr R. Solar cheilitis. American Academy of Oral Medicine, 2008. Available at: https://maaom.memberclicks. net/index.php?option=com_content&view=article&id=137: solar-cheilitis&catid=22:patient-condition-information&Itemid=120. Accessed March 27, 2020.
28. Poitevin NA, Rodrigues SR, Weigert KL, et al. Actinic cheilitis: proposition and reproducibility of a clinical criterion. BDJOpen. 2017;3:17016.
29. Buchner L, Vamvakias G, Rom D. Validation of a photonumeric wrinkle assessment scale for assessing nasolabial fold wrinkles. Plast Reconstr Surg. 2010;126(2):596-601.
30. Carruthers J, Jones D, Hardas B, et al. Development and validation of a photonumeric scale for evaluation of volume deficit of the temple. Dermatol Surg. 2016;42(Suppl 1):S203-S210.
31. Niforos F, Liew S, Acquilla R, et al. Creation and validation of a photonumeric scale to assess volume deficiency in the infraorbital region. Dermatol Surg. 2017;43(5):684-691.
32. Farage MA, Miller KW, Elsner P, Maibach HI. Intrinsic and extrinsic factors in skin ageing: a review. Int J Cosmet Sci. 2008;30(2):87-95.
33. Rodriguez-Blanco I, Florez A, Paredes-Suarez C, et al. Use of lip photoprotection in patients suffering from actinic cheilitis. Eur J Dermatol. 2019;29(4):383-386.
34. Draelos ZD. New treatments for restoring impaired epidermal barrier permeability: skin barrier repair creams. Clin Dermatol. 2012;30(3):345-348.
35. Verdier-Sevrain S, Bonte F. Skin hydration: a review on its molecular mechanisms. J Cosmet Dermatol. 2007;6(2):75-82.
AUTHOR CORRESPONDENCE
Zoe Diana Draelos MD zdraelos@northstate.net
