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Cosmetic benefits of a novel biomimetic lamellar formulation containing niacinamide in healthy females with oily, blemish-prone skin in a randomised proof-of-concept study.

Abstract

OBJECTIVE

A randomised study was designed to evaluate the potential cosmetic benefit of a biomimetic, niacinamide-containing moisturising cream in oily, blemish-prone skin.

METHODS

Healthy adult women with oily, blemish-prone skin were randomised to one of three treatment groups: test, control, or positive control. In the test group, subjects used the test product (containing 4% niacinamide), plus the standard cleanser (Simple® Kind to Skin Moisturizing Facial Wash). In the control group, subjects received no moisturiser but used the standard cleanser. In the positive control group, subjects used Vivatinell Acnecinamide® Gel Cream (containing 4% niacinamide) as a moisturiser and Neutrogena Visibly Clear® Spot Clearing Facial Wash (containing 2% salicylic acid) as a cleanser. The positive control regimen was included to provide a comparison for estimates of effect size. The primary objective was to evaluate skin moisturisation as a change from baseline in corneometer values at 8 hours for the test regimen versus the control regimen. Analysis of covariance was applied for the primary efficacy analysis.

RESULTS

A total of 132 subjects were randomised with 44 included in each treatment group. A significant difference was observed in the primary endpoint for the test regimen compared with the control regimen (least squares mean difference [95% CI]: 3.12 [0.68, 5.56], p=0.0128). A trend was observed in favour of the positive control regimen compared with the control regimen. Secondary measurements of moisturisation supported the primary efficacy outcome. Assessment of blemishes showed a significant difference between the test regimen versus the control regimen for change from baseline in mean total blemish count at Week 8 (least squares mean difference [95% CI]: -1.80 [-3.41, -0.19], p=0.0290). No statistical comparisons between the positive control group and the test group were performed.

CONCLUSION

This study provides proof-of-concept evidence that a novel lamellar lipid moisturiser containing niacinamide, in combination with a standard cleanser, can help moisturise the skin and provide an overall improvement in the complexion appearance of people with blemish-prone skin.

STUDY REGISTRATION

NCT03093181.

Authors+Show Affiliations

GlaxoSmithKline Consumer Healthcare Brazil, São Paulo Medical Affairs and Clinical Operations, 1240 Rua Hungria, São Paulo, SP, Brazil.GlaxoSmithKline Consumer Healthcare, Medical Affairs, St George's Avenue, Skin Health, Weybridge, KT13 0DE, UK.GlaxoSmithKline Consumer Healthcare, Medical Affairs, Skin Health, 184 Liberty Corner Road, Warren, NJ, 07059, USA.GlaxoSmithKline Consumer Healthcare, Medical Affairs, St George's Avenue, Skin Health, Weybridge, KT13 0DE, UK.GlaxoSmithKline Consumer Healthcare, Medical Affairs, St George's Avenue, Skin Health, Weybridge, KT13 0DE, UK.GlaxoSmithKline Consumer Healthcare, Research and Development, St George's Avenue, Skin Health, Weybridge, KT13 0DE, UK.GlaxoSmithKline Consumer Healthcare Brazil, São Paulo Medical Affairs and Clinical Operations, 1240 Rua Hungria, São Paulo, SP, Brazil.Rua General Osório, Azidus Brasil - 507, Vila Martina Valinhos, SP, Brazil.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

31461548

Citation

Caetano, Joao, et al. "Cosmetic Benefits of a Novel Biomimetic Lamellar Formulation Containing Niacinamide in Healthy Females With Oily, Blemish-prone Skin in a Randomised Proof-of-concept Study." International Journal of Cosmetic Science, 2019.
Caetano J, Gfeller CF, Mahalingam H, et al. Cosmetic benefits of a novel biomimetic lamellar formulation containing niacinamide in healthy females with oily, blemish-prone skin in a randomised proof-of-concept study. Int J Cosmet Sci. 2019.
Caetano, J., Gfeller, C. F., Mahalingam, H., Cargill, M., Thomson, M., Moore, D., ... Doi, R. (2019). Cosmetic benefits of a novel biomimetic lamellar formulation containing niacinamide in healthy females with oily, blemish-prone skin in a randomised proof-of-concept study. International Journal of Cosmetic Science, doi:10.1111/ics.12576.
Caetano J, et al. Cosmetic Benefits of a Novel Biomimetic Lamellar Formulation Containing Niacinamide in Healthy Females With Oily, Blemish-prone Skin in a Randomised Proof-of-concept Study. Int J Cosmet Sci. 2019 Aug 28; PubMed PMID: 31461548.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Cosmetic benefits of a novel biomimetic lamellar formulation containing niacinamide in healthy females with oily, blemish-prone skin in a randomised proof-of-concept study. AU - Caetano,Joao, AU - Gfeller,Christoph F, AU - Mahalingam,Harish, AU - Cargill,Matthew, AU - Thomson,Michael, AU - Moore,David, AU - Vila,Ricardo, AU - Doi,Regina, Y1 - 2019/08/28/ PY - 2019/8/29/entrez PY - 2019/8/29/pubmed PY - 2019/8/29/medline KW - Blemish KW - Moisturising cream KW - Niacinamide KW - Skin barrier KW - Skin physiology/structure JF - International journal of cosmetic science JO - Int J Cosmet Sci N2 - OBJECTIVE: A randomised study was designed to evaluate the potential cosmetic benefit of a biomimetic, niacinamide-containing moisturising cream in oily, blemish-prone skin. METHODS: Healthy adult women with oily, blemish-prone skin were randomised to one of three treatment groups: test, control, or positive control. In the test group, subjects used the test product (containing 4% niacinamide), plus the standard cleanser (Simple® Kind to Skin Moisturizing Facial Wash). In the control group, subjects received no moisturiser but used the standard cleanser. In the positive control group, subjects used Vivatinell Acnecinamide® Gel Cream (containing 4% niacinamide) as a moisturiser and Neutrogena Visibly Clear® Spot Clearing Facial Wash (containing 2% salicylic acid) as a cleanser. The positive control regimen was included to provide a comparison for estimates of effect size. The primary objective was to evaluate skin moisturisation as a change from baseline in corneometer values at 8 hours for the test regimen versus the control regimen. Analysis of covariance was applied for the primary efficacy analysis. RESULTS: A total of 132 subjects were randomised with 44 included in each treatment group. A significant difference was observed in the primary endpoint for the test regimen compared with the control regimen (least squares mean difference [95% CI]: 3.12 [0.68, 5.56], p=0.0128). A trend was observed in favour of the positive control regimen compared with the control regimen. Secondary measurements of moisturisation supported the primary efficacy outcome. Assessment of blemishes showed a significant difference between the test regimen versus the control regimen for change from baseline in mean total blemish count at Week 8 (least squares mean difference [95% CI]: -1.80 [-3.41, -0.19], p=0.0290). No statistical comparisons between the positive control group and the test group were performed. CONCLUSION: This study provides proof-of-concept evidence that a novel lamellar lipid moisturiser containing niacinamide, in combination with a standard cleanser, can help moisturise the skin and provide an overall improvement in the complexion appearance of people with blemish-prone skin. STUDY REGISTRATION: NCT03093181. SN - 1468-2494 UR - https://www.unboundmedicine.com/medline/citation/31461548/Cosmetic_benefits_of_a_novel_biomimetic_lamellar_formulation_containing_niacinamide_in_healthy_females_with_oily,_blemish-prone_skin_in_a_randomised_proof-of-concept_study L2 - https://doi.org/10.1111/ics.12576 DB - PRIME DP - Unbound Medicine ER -