A series of in vitro and human studies of a novel lip cream formulation for protecting against environmental triggers of recurrent herpes labialis
Christoph F Gfeller,1 Rita Wanser,2 Harish Mahalingam,2 David J Moore,3 Xuying Wang,4 Connie B Lin,4 Gilbert Shanga,5 Gary Grove,6 Anthony V Rawlings7 1GlaxoSmithKline Consumer Healthcare, Medical Affairs Skin Health, Weybridge, Surrey, UK; 2GlaxoSmithKline Consumer Healthcare, Medical Affairs Skin...
| Main Authors: | , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Dove Medical Press
2019-03-01
|
| Series: | Clinical, Cosmetic and Investigational Dermatology |
| Subjects: | |
| Online Access: | https://www.dovepress.com/a-series-of-in-vitro-and-human-studies-of-a-novel-lip-cream-formulatio-peer-reviewed-article-CCID |
| _version_ | 1818651670295347200 |
|---|---|
| author | Gfeller CF Wanser R Mahalingam H Moore DJ Wang X Lin CB Shanga G Grove G Rawlings AV |
| author_facet | Gfeller CF Wanser R Mahalingam H Moore DJ Wang X Lin CB Shanga G Grove G Rawlings AV |
| author_sort | Gfeller CF |
| collection | DOAJ |
| description | Christoph F Gfeller,1 Rita Wanser,2 Harish Mahalingam,2 David J Moore,3 Xuying Wang,4 Connie B Lin,4 Gilbert Shanga,5 Gary Grove,6 Anthony V Rawlings7 1GlaxoSmithKline Consumer Healthcare, Medical Affairs Skin Health, Weybridge, Surrey, UK; 2GlaxoSmithKline Consumer Healthcare, Medical Affairs Skin Health, Warren, NJ, USA; 3GlaxoSmithKline Consumer Healthcare, R&D Innovation Skin Health, Weybridge, Surrey, UK; 4GlaxoSmithKline Consumer Healthcare, R&D Innovation Skin Health, Collegeville, PA, USA; 5GSK Consumer Healthcare, Biostatistics, Warren, NJ, USA; 6cyberDERM, Inc., Broomall, PA, USA; 7AVR Consulting, Ltd., Cheshire, UK Purpose: These studies describe the testing of a novel, daily-use lip cream designed for individuals with lips prone to recurrent herpes labialis (RHL) that protects against environmental triggers.Subjects and methods: In vitro occlusive and in vitro and in vivo photoprotection analyses, a characterization of normal vs dry lips, and a randomized, evaluator-blinded, clinical trial that assessed the lip cream in healthy subjects with dry lips were conducted. In the clinical trial, subjects applied the lip cream or were untreated and evaluated using transepidermal water loss (TEWL), corneometry, visual assessments of lip dryness, expert photographic evaluations, and subject-rated outcomes.Results: The lip cream’s in vitro water vapor transmission rate (84.1 g/(m2 h)) indicated moderate occlusivity. The lip cream, but not placebo or control (water), reduced ultraviolet A (UVA)- and UVB-induced DNA damage, and tumor necrosis factor-α (EpiDermFT) and prostaglandin E2 release (EpiDermFT and EpiGingival™). The lip cream’s in vivo sun protection factor (SPF) was 12.2 (lower confidence limit, 11.3) and SPF/UVA protection factor ratio was 0.9. The characterization of dry vs normal lips identified differences in moisturization. In the clinical trial, the lip cream significantly decreased TEWL (difference: –7.19 [95% CI: −11.41, –2.98]; P<0.01), increased corneometry (difference: 4.62 [95% CI: 1.05, 8.19]; P<0.05), and reduced visual dryness (difference: –1.48 [95% CI: 2.24, –0.71]; P<0.001) compared to untreated subjects. Significant benefits were also observed on expert photographic assessments of scaling (difference: –0.89 [95% CI: −1.75, –0.03]; P< 0.05), cupping (difference: –1.50 [95% CI: −2.30, –0.70]; P<0.001), and healthy appearance (difference: –1.44 [95% CI: −2.29, –0.58]; P<0.01); differences in overall healthy appearance were not significant (P=0.51). Subject-rated assessments indicated improvements in cracking, dryness, and flaking in the lip cream group but worsening in untreated subjects.Conclusion: These studies indicate that this novel, daily-use lip cream protects against UV radiation, drying, and chapping, which are established environmental RHL triggers. Keywords: herpes simplex virus, barrier function, lip care, UV radiation |
| first_indexed | 2024-12-17T02:09:48Z |
| format | Article |
| id | doaj.art-684a27ee0b9f49d0bf530ed9a6a1535b |
| institution | Directory Open Access Journal |
| issn | 1178-7015 |
| language | English |
| last_indexed | 2024-12-17T02:09:48Z |
| publishDate | 2019-03-01 |
| publisher | Dove Medical Press |
| record_format | Article |
| series | Clinical, Cosmetic and Investigational Dermatology |
| spelling | doaj.art-684a27ee0b9f49d0bf530ed9a6a1535b2022-12-21T22:07:35ZengDove Medical PressClinical, Cosmetic and Investigational Dermatology1178-70152019-03-01Volume 1219320844700A series of in vitro and human studies of a novel lip cream formulation for protecting against environmental triggers of recurrent herpes labialisGfeller CFWanser RMahalingam HMoore DJWang XLin CBShanga GGrove GRawlings AVChristoph F Gfeller,1 Rita Wanser,2 Harish Mahalingam,2 David J Moore,3 Xuying Wang,4 Connie B Lin,4 Gilbert Shanga,5 Gary Grove,6 Anthony V Rawlings7 1GlaxoSmithKline Consumer Healthcare, Medical Affairs Skin Health, Weybridge, Surrey, UK; 2GlaxoSmithKline Consumer Healthcare, Medical Affairs Skin Health, Warren, NJ, USA; 3GlaxoSmithKline Consumer Healthcare, R&D Innovation Skin Health, Weybridge, Surrey, UK; 4GlaxoSmithKline Consumer Healthcare, R&D Innovation Skin Health, Collegeville, PA, USA; 5GSK Consumer Healthcare, Biostatistics, Warren, NJ, USA; 6cyberDERM, Inc., Broomall, PA, USA; 7AVR Consulting, Ltd., Cheshire, UK Purpose: These studies describe the testing of a novel, daily-use lip cream designed for individuals with lips prone to recurrent herpes labialis (RHL) that protects against environmental triggers.Subjects and methods: In vitro occlusive and in vitro and in vivo photoprotection analyses, a characterization of normal vs dry lips, and a randomized, evaluator-blinded, clinical trial that assessed the lip cream in healthy subjects with dry lips were conducted. In the clinical trial, subjects applied the lip cream or were untreated and evaluated using transepidermal water loss (TEWL), corneometry, visual assessments of lip dryness, expert photographic evaluations, and subject-rated outcomes.Results: The lip cream’s in vitro water vapor transmission rate (84.1 g/(m2 h)) indicated moderate occlusivity. The lip cream, but not placebo or control (water), reduced ultraviolet A (UVA)- and UVB-induced DNA damage, and tumor necrosis factor-α (EpiDermFT) and prostaglandin E2 release (EpiDermFT and EpiGingival™). The lip cream’s in vivo sun protection factor (SPF) was 12.2 (lower confidence limit, 11.3) and SPF/UVA protection factor ratio was 0.9. The characterization of dry vs normal lips identified differences in moisturization. In the clinical trial, the lip cream significantly decreased TEWL (difference: –7.19 [95% CI: −11.41, –2.98]; P<0.01), increased corneometry (difference: 4.62 [95% CI: 1.05, 8.19]; P<0.05), and reduced visual dryness (difference: –1.48 [95% CI: 2.24, –0.71]; P<0.001) compared to untreated subjects. Significant benefits were also observed on expert photographic assessments of scaling (difference: –0.89 [95% CI: −1.75, –0.03]; P< 0.05), cupping (difference: –1.50 [95% CI: −2.30, –0.70]; P<0.001), and healthy appearance (difference: –1.44 [95% CI: −2.29, –0.58]; P<0.01); differences in overall healthy appearance were not significant (P=0.51). Subject-rated assessments indicated improvements in cracking, dryness, and flaking in the lip cream group but worsening in untreated subjects.Conclusion: These studies indicate that this novel, daily-use lip cream protects against UV radiation, drying, and chapping, which are established environmental RHL triggers. Keywords: herpes simplex virus, barrier function, lip care, UV radiationhttps://www.dovepress.com/a-series-of-in-vitro-and-human-studies-of-a-novel-lip-cream-formulatio-peer-reviewed-article-CCIDherpes simplex virusbarrier functionlip careUV radiation. |
| spellingShingle | Gfeller CF Wanser R Mahalingam H Moore DJ Wang X Lin CB Shanga G Grove G Rawlings AV A series of in vitro and human studies of a novel lip cream formulation for protecting against environmental triggers of recurrent herpes labialis Clinical, Cosmetic and Investigational Dermatology herpes simplex virus barrier function lip care UV radiation. |
| title | A series of in vitro and human studies of a novel lip cream formulation for protecting against environmental triggers of recurrent herpes labialis |
| title_full | A series of in vitro and human studies of a novel lip cream formulation for protecting against environmental triggers of recurrent herpes labialis |
| title_fullStr | A series of in vitro and human studies of a novel lip cream formulation for protecting against environmental triggers of recurrent herpes labialis |
| title_full_unstemmed | A series of in vitro and human studies of a novel lip cream formulation for protecting against environmental triggers of recurrent herpes labialis |
| title_short | A series of in vitro and human studies of a novel lip cream formulation for protecting against environmental triggers of recurrent herpes labialis |
| title_sort | series of in vitro and human studies of a novel lip cream formulation for protecting against environmental triggers of recurrent herpes labialis |
| topic | herpes simplex virus barrier function lip care UV radiation. |
| url | https://www.dovepress.com/a-series-of-in-vitro-and-human-studies-of-a-novel-lip-cream-formulatio-peer-reviewed-article-CCID |
| work_keys_str_mv | AT gfellercf aseriesofinvitroandhumanstudiesofanovellipcreamformulationforprotectingagainstenvironmentaltriggersofrecurrentherpeslabialis AT wanserr aseriesofinvitroandhumanstudiesofanovellipcreamformulationforprotectingagainstenvironmentaltriggersofrecurrentherpeslabialis AT mahalingamh aseriesofinvitroandhumanstudiesofanovellipcreamformulationforprotectingagainstenvironmentaltriggersofrecurrentherpeslabialis AT mooredj aseriesofinvitroandhumanstudiesofanovellipcreamformulationforprotectingagainstenvironmentaltriggersofrecurrentherpeslabialis AT wangx aseriesofinvitroandhumanstudiesofanovellipcreamformulationforprotectingagainstenvironmentaltriggersofrecurrentherpeslabialis AT lincb aseriesofinvitroandhumanstudiesofanovellipcreamformulationforprotectingagainstenvironmentaltriggersofrecurrentherpeslabialis AT shangag aseriesofinvitroandhumanstudiesofanovellipcreamformulationforprotectingagainstenvironmentaltriggersofrecurrentherpeslabialis AT groveg aseriesofinvitroandhumanstudiesofanovellipcreamformulationforprotectingagainstenvironmentaltriggersofrecurrentherpeslabialis AT rawlingsav aseriesofinvitroandhumanstudiesofanovellipcreamformulationforprotectingagainstenvironmentaltriggersofrecurrentherpeslabialis AT gfellercf seriesofinvitroandhumanstudiesofanovellipcreamformulationforprotectingagainstenvironmentaltriggersofrecurrentherpeslabialis AT wanserr seriesofinvitroandhumanstudiesofanovellipcreamformulationforprotectingagainstenvironmentaltriggersofrecurrentherpeslabialis AT mahalingamh seriesofinvitroandhumanstudiesofanovellipcreamformulationforprotectingagainstenvironmentaltriggersofrecurrentherpeslabialis AT mooredj seriesofinvitroandhumanstudiesofanovellipcreamformulationforprotectingagainstenvironmentaltriggersofrecurrentherpeslabialis AT wangx seriesofinvitroandhumanstudiesofanovellipcreamformulationforprotectingagainstenvironmentaltriggersofrecurrentherpeslabialis AT lincb seriesofinvitroandhumanstudiesofanovellipcreamformulationforprotectingagainstenvironmentaltriggersofrecurrentherpeslabialis AT shangag seriesofinvitroandhumanstudiesofanovellipcreamformulationforprotectingagainstenvironmentaltriggersofrecurrentherpeslabialis AT groveg seriesofinvitroandhumanstudiesofanovellipcreamformulationforprotectingagainstenvironmentaltriggersofrecurrentherpeslabialis AT rawlingsav seriesofinvitroandhumanstudiesofanovellipcreamformulationforprotectingagainstenvironmentaltriggersofrecurrentherpeslabialis |