A Prospective, Randomized, Double-Blind, Vehicle-Controlled Study Evaluating the Efficacy, Safety, and Patient Satisfaction of Tretinoin 0.05% Lotion for Chest Rejuvenation.
Acne Vulgaris
/ drug therapy
Administration, Cutaneous
Adult
Aged
Double-Blind Method
Emollients
/ therapeutic use
Emulsions
/ therapeutic use
Glycerol
/ adverse effects
Humans
Hyaluronic Acid
/ adverse effects
Middle Aged
Patient Satisfaction
Prospective Studies
Quality of Life
Rejuvenation
Severity of Illness Index
Skin Aging
Treatment Outcome
Tretinoin
/ adverse effects
Journal
Journal of drugs in dermatology : JDD
ISSN: 1545-9616
Titre abrégé: J Drugs Dermatol
Pays: United States
ID NLM: 101160020
Informations de publication
Date de publication:
01 Jun 2022
01 Jun 2022
Historique:
entrez:
8
6
2022
pubmed:
9
6
2022
medline:
11
6
2022
Statut:
ppublish
Résumé
There is increasing interest in non-invasive options for chest rejuvenation with minimal to no downtime. Topical retinoids have long been used to correct photoaging due to their ability to promote epidermal hyperplasia, matrix metalloproteinase inhibition, collagen synthesis, and dispersion of melanin granules. Topical retinoid use is often limited by the ensuing irritation that occurs with initial use and resolves after about one month. Vehicle of delivery is a key factor to consider in order to minimize irritation and increase patient satisfaction. Micronized tretinoin 0.05% suspended in a polymer emulsion of hydrating ingredients (sodium hyaluronate, soluble collagen, and glycerin) is designed to aid in reducing irritation while ensuring uniform drug delivery. The primary objective of our study is to evaluate the safety, efficacy, and patient satisfaction of tretinoin 0.05% lotion for nonprocedural photorejuvenation of the chest. A total of 29 patients completed the trial, average age of 54.42 years (37-66 years old), Fitzpatrick II-IV skin types. Both the active and vehicle groups showed 30-40% improvement at day 180 according to the blinded evaluator mean percent improvement. Investigator global aesthetic improvement scale also trended towards improvement in both groups, with most patients exhibiting "improvement." Both the active and vehicle groups showed a significant change over time according to the nine-point photodamage and wrinkling scale, P<0.001 and P=0.007 (single factor ANOVA), respectively. The Fabi Bolton Wrinkle Scale also demonstrated improvement from screening to day 180; however, there was no statistical significance at any time point. At day 90, the active group had statistically significantly more erythema than the vehicle group (P<0.001), although both groups were only mild. At day 180, erythema decreased in both groups with the active group being similar to the vehicle group, 0.50±0.73 versus 0.09±0.30, respectively. Subjects in both the active and vehicle groups were equally satisfied at day 180, (2.38±1.15 in the active group versus 2.30±1.16 in the treatment group), with most subjects feeling "satisfied" with their results by day 180. This was also reflected in the subject global aesthetic improvement scale with most subjects noting noticeable improvement in the appearance of their chest from day 30 to day 180. Tretinoin 0.05% lotion delivered in a proprietary blend of hydrating ingredients offers a safe and efficacious option that has minimal downtime for patients seeking non-procedural photo-rejuvenation of the chest. The proprietary vehicle, containing hyaluronic acid, glycerin, and collagen, was crucial in minimizing irritation and producing at least a one-point improvement according to the 9 point photodamage scale and 30-40% improvement in photodamage as noted by the blinded evaluator percent improvement score in both the vehicle and active groups. J Drugs Dermatol. 2022;21(6):645-652. doi:10.36849/JDD.6658.
Sections du résumé
BACKGROUND
BACKGROUND
There is increasing interest in non-invasive options for chest rejuvenation with minimal to no downtime. Topical retinoids have long been used to correct photoaging due to their ability to promote epidermal hyperplasia, matrix metalloproteinase inhibition, collagen synthesis, and dispersion of melanin granules. Topical retinoid use is often limited by the ensuing irritation that occurs with initial use and resolves after about one month. Vehicle of delivery is a key factor to consider in order to minimize irritation and increase patient satisfaction. Micronized tretinoin 0.05% suspended in a polymer emulsion of hydrating ingredients (sodium hyaluronate, soluble collagen, and glycerin) is designed to aid in reducing irritation while ensuring uniform drug delivery.
OBJECTIVE
OBJECTIVE
The primary objective of our study is to evaluate the safety, efficacy, and patient satisfaction of tretinoin 0.05% lotion for nonprocedural photorejuvenation of the chest.
RESULTS
RESULTS
A total of 29 patients completed the trial, average age of 54.42 years (37-66 years old), Fitzpatrick II-IV skin types. Both the active and vehicle groups showed 30-40% improvement at day 180 according to the blinded evaluator mean percent improvement. Investigator global aesthetic improvement scale also trended towards improvement in both groups, with most patients exhibiting "improvement." Both the active and vehicle groups showed a significant change over time according to the nine-point photodamage and wrinkling scale, P<0.001 and P=0.007 (single factor ANOVA), respectively. The Fabi Bolton Wrinkle Scale also demonstrated improvement from screening to day 180; however, there was no statistical significance at any time point. At day 90, the active group had statistically significantly more erythema than the vehicle group (P<0.001), although both groups were only mild. At day 180, erythema decreased in both groups with the active group being similar to the vehicle group, 0.50±0.73 versus 0.09±0.30, respectively. Subjects in both the active and vehicle groups were equally satisfied at day 180, (2.38±1.15 in the active group versus 2.30±1.16 in the treatment group), with most subjects feeling "satisfied" with their results by day 180. This was also reflected in the subject global aesthetic improvement scale with most subjects noting noticeable improvement in the appearance of their chest from day 30 to day 180.
CONCLUSION
CONCLUSIONS
Tretinoin 0.05% lotion delivered in a proprietary blend of hydrating ingredients offers a safe and efficacious option that has minimal downtime for patients seeking non-procedural photo-rejuvenation of the chest. The proprietary vehicle, containing hyaluronic acid, glycerin, and collagen, was crucial in minimizing irritation and producing at least a one-point improvement according to the 9 point photodamage scale and 30-40% improvement in photodamage as noted by the blinded evaluator percent improvement score in both the vehicle and active groups. J Drugs Dermatol. 2022;21(6):645-652. doi:10.36849/JDD.6658.
Identifiants
pubmed: 35674757
pii: S1545961622P0645X
doi: 10.36849/JDD.6658
doi:
Substances chimiques
Emollients
0
Emulsions
0
Tretinoin
5688UTC01R
Hyaluronic Acid
9004-61-9
Glycerol
PDC6A3C0OX
Types de publication
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM