Cargando…

A Prospective, Randomized, Comparative Study of Topical Minocycline Gel 4% with Topical Clindamycin Phosphate Gel 1% in Indian Patients with Acne Vulgaris

Acne vulgaris is characterized by inflammatory and non-inflammatory skin lesions with a high prevalence among adolescents in India. Not enough studies are reported on the use of topical antibiotics for the management of acne in the Indian population. The proposed study aims to compare the efficacy a...

Descripción completa

Detalles Bibliográficos
Autores principales: Shah, Bela, Mistry, Deval, Gonsalves, Nelry, Vasani, Presha, Dhoot, Dhiraj, Barkate, Hanmant
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10526007/
https://www.ncbi.nlm.nih.gov/pubmed/37760751
http://dx.doi.org/10.3390/antibiotics12091455
_version_ 1785110919825588224
author Shah, Bela
Mistry, Deval
Gonsalves, Nelry
Vasani, Presha
Dhoot, Dhiraj
Barkate, Hanmant
author_facet Shah, Bela
Mistry, Deval
Gonsalves, Nelry
Vasani, Presha
Dhoot, Dhiraj
Barkate, Hanmant
author_sort Shah, Bela
collection PubMed
description Acne vulgaris is characterized by inflammatory and non-inflammatory skin lesions with a high prevalence among adolescents in India. Not enough studies are reported on the use of topical antibiotics for the management of acne in the Indian population. The proposed study aims to compare the efficacy and safety of topical minocycline gel 4% with topical clindamycin gel 1% in the Indian population. A randomized, open-label, double-arm study was planned at two centers in India. One hundred patients were enrolled and randomized equally to two treatment arms. The drugs were applied once daily, preferably at the same time each day. The number of inflammatory and non-inflammatory lesions, as well as the investigator’s global assessment (IGA), were obtained at the baseline and on weeks 3, 6, 9, and 12. The change in these parameters from baseline to week 12 was compared between the two treatment arms. A tolerability assessment was also performed on selected parameters. The age of patients ranged between 14 and 31 years, with female preponderance in each arm. On week 12, the percent change in inflammatory and non-inflammatory lesions in the minocycline 4% arm was significantly higher than in the clindamycin 1% arm (p < 0.0001). The IGA treatment success was significantly higher in the minocycline arm compared to the clindamycin arm on weeks 9 and 12, with p-values of 0.001 and 0.015, respectively. Tolerability assessment revealed significantly improved parameter performance in the minocycline arm compared to the clindamycin arm. On subgroup analysis, in adolescents, minocycline was found to be more efficacious than clindamycin. The comparative assessment resulted in a significantly improved performance of minocycline gel 4% compared to clindamycin gel 1% in the Indian population, thus making it a preferred choice for the treatment of moderate-to-severe acne in India.
format Online
Article
Text
id pubmed-10526007
institution National Center for Biotechnology Information
language English
publishDate 2023
publisher MDPI
record_format MEDLINE/PubMed
spelling pubmed-105260072023-09-28 A Prospective, Randomized, Comparative Study of Topical Minocycline Gel 4% with Topical Clindamycin Phosphate Gel 1% in Indian Patients with Acne Vulgaris Shah, Bela Mistry, Deval Gonsalves, Nelry Vasani, Presha Dhoot, Dhiraj Barkate, Hanmant Antibiotics (Basel) Article Acne vulgaris is characterized by inflammatory and non-inflammatory skin lesions with a high prevalence among adolescents in India. Not enough studies are reported on the use of topical antibiotics for the management of acne in the Indian population. The proposed study aims to compare the efficacy and safety of topical minocycline gel 4% with topical clindamycin gel 1% in the Indian population. A randomized, open-label, double-arm study was planned at two centers in India. One hundred patients were enrolled and randomized equally to two treatment arms. The drugs were applied once daily, preferably at the same time each day. The number of inflammatory and non-inflammatory lesions, as well as the investigator’s global assessment (IGA), were obtained at the baseline and on weeks 3, 6, 9, and 12. The change in these parameters from baseline to week 12 was compared between the two treatment arms. A tolerability assessment was also performed on selected parameters. The age of patients ranged between 14 and 31 years, with female preponderance in each arm. On week 12, the percent change in inflammatory and non-inflammatory lesions in the minocycline 4% arm was significantly higher than in the clindamycin 1% arm (p < 0.0001). The IGA treatment success was significantly higher in the minocycline arm compared to the clindamycin arm on weeks 9 and 12, with p-values of 0.001 and 0.015, respectively. Tolerability assessment revealed significantly improved parameter performance in the minocycline arm compared to the clindamycin arm. On subgroup analysis, in adolescents, minocycline was found to be more efficacious than clindamycin. The comparative assessment resulted in a significantly improved performance of minocycline gel 4% compared to clindamycin gel 1% in the Indian population, thus making it a preferred choice for the treatment of moderate-to-severe acne in India. MDPI 2023-09-19 /pmc/articles/PMC10526007/ /pubmed/37760751 http://dx.doi.org/10.3390/antibiotics12091455 Text en © 2023 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Shah, Bela
Mistry, Deval
Gonsalves, Nelry
Vasani, Presha
Dhoot, Dhiraj
Barkate, Hanmant
A Prospective, Randomized, Comparative Study of Topical Minocycline Gel 4% with Topical Clindamycin Phosphate Gel 1% in Indian Patients with Acne Vulgaris
title A Prospective, Randomized, Comparative Study of Topical Minocycline Gel 4% with Topical Clindamycin Phosphate Gel 1% in Indian Patients with Acne Vulgaris
title_full A Prospective, Randomized, Comparative Study of Topical Minocycline Gel 4% with Topical Clindamycin Phosphate Gel 1% in Indian Patients with Acne Vulgaris
title_fullStr A Prospective, Randomized, Comparative Study of Topical Minocycline Gel 4% with Topical Clindamycin Phosphate Gel 1% in Indian Patients with Acne Vulgaris
title_full_unstemmed A Prospective, Randomized, Comparative Study of Topical Minocycline Gel 4% with Topical Clindamycin Phosphate Gel 1% in Indian Patients with Acne Vulgaris
title_short A Prospective, Randomized, Comparative Study of Topical Minocycline Gel 4% with Topical Clindamycin Phosphate Gel 1% in Indian Patients with Acne Vulgaris
title_sort prospective, randomized, comparative study of topical minocycline gel 4% with topical clindamycin phosphate gel 1% in indian patients with acne vulgaris
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10526007/
https://www.ncbi.nlm.nih.gov/pubmed/37760751
http://dx.doi.org/10.3390/antibiotics12091455
work_keys_str_mv AT shahbela aprospectiverandomizedcomparativestudyoftopicalminocyclinegel4withtopicalclindamycinphosphategel1inindianpatientswithacnevulgaris
AT mistrydeval aprospectiverandomizedcomparativestudyoftopicalminocyclinegel4withtopicalclindamycinphosphategel1inindianpatientswithacnevulgaris
AT gonsalvesnelry aprospectiverandomizedcomparativestudyoftopicalminocyclinegel4withtopicalclindamycinphosphategel1inindianpatientswithacnevulgaris
AT vasanipresha aprospectiverandomizedcomparativestudyoftopicalminocyclinegel4withtopicalclindamycinphosphategel1inindianpatientswithacnevulgaris
AT dhootdhiraj aprospectiverandomizedcomparativestudyoftopicalminocyclinegel4withtopicalclindamycinphosphategel1inindianpatientswithacnevulgaris
AT barkatehanmant aprospectiverandomizedcomparativestudyoftopicalminocyclinegel4withtopicalclindamycinphosphategel1inindianpatientswithacnevulgaris
AT shahbela prospectiverandomizedcomparativestudyoftopicalminocyclinegel4withtopicalclindamycinphosphategel1inindianpatientswithacnevulgaris
AT mistrydeval prospectiverandomizedcomparativestudyoftopicalminocyclinegel4withtopicalclindamycinphosphategel1inindianpatientswithacnevulgaris
AT gonsalvesnelry prospectiverandomizedcomparativestudyoftopicalminocyclinegel4withtopicalclindamycinphosphategel1inindianpatientswithacnevulgaris
AT vasanipresha prospectiverandomizedcomparativestudyoftopicalminocyclinegel4withtopicalclindamycinphosphategel1inindianpatientswithacnevulgaris
AT dhootdhiraj prospectiverandomizedcomparativestudyoftopicalminocyclinegel4withtopicalclindamycinphosphategel1inindianpatientswithacnevulgaris
AT barkatehanmant prospectiverandomizedcomparativestudyoftopicalminocyclinegel4withtopicalclindamycinphosphategel1inindianpatientswithacnevulgaris