Efficacy and safety of a nano-emulsion gel formulation of adapalene 0.1% and clindamycin 1% combination in acne vulgaris: A randomized, open label, active-controlled, multicentric, phase IV clinical trial

Prasad, S. E.; Mukhopadhyay, A. K.; Kubavat, Amit; Kelkar, Amit; Modi, Ajay; Swarnkar, Bhavesh; Bajaj, Bobby; Vedamurthy, Maya; Sheikh, Saifuddin; Mittal, Ravindra

doi:10.4103/0378-6323.98077

Cited by 28 publications

(8 citation statements)

References 18 publications

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“…Topical retinoids in combination with clindamycin or BPO is the first-line combination therapy recommended for mild to moderate acne. Previous studies using this type of combination therapy have reported reductions in non-inflammatory, inflammatory, and total acne lesion counts of 42.5%, 55%, and 46.7%, respectively, 6 58.4%, 71.4%, and 62.7%, respectively, 7 and 68% ± 0.07%, 77.00% ± 0.06%, and 70% ± 0.05%, respectively. 8 In our study, we found reductions of 95.54% for non-inflammatory lesions, 88.89% for inflammatory papules, 92.91% for inflammatory pustules, and 90.31% for the total lesion count.…”

Section: Discussionmentioning

confidence: 83%

Efficacy and tolerability of 0.1% adapalene with 1% clindamycin versus 0.1% adapalene with 2.5% benzoyl peroxide in the treatment of acne vulgaris

Inbamani¹,

Manickam²,

Gopalan

2023

International Journal of Dermatology and Venereology

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Objective: Combination therapy is currently the preferred acne treatment. We conducted this study to compare the efficacy and tolerability of 0.1% adapalene with 1% clindamycin versus 0.1% adapalene with 2.5% benzoyl peroxide (BPO) in the treatment of acne vulgaris. Methods: This study was conducted over a period of 1 year from September 2014 to September 2015. One-hundred patients aged 14 to 30 years with mild to moderate acne vulgaris were included. The patients were randomly allocated to 2 equal groups (n = 50 in each group), and received a topical combination of 0.1% adapalene with 1% clindamycin andtopical combination of 0.1% adapalene with 2.5% BPO, respectively). The efficacy and tolerability of two treatments were compared. The unpaired student t test was used to compare the difference in continuous variables between 2 groups, while the chi-square test or Fisher exact test was used for categorical variables. Results: One-hundred patients with mild to moderate acne vulgaris were randomly allocated to 2 equal groups (n = 50 in each group). After 12 weeks of treatment, there were no significant differences between the adapalene-clindamycin and adapalene-BPO in the mean reductions in the numbers of non-inflammatory lesions (11.16 ± 8.01 and 11.12 ± 8.62, respectively), inflammatory papules (49.78 ± 37.57 and 50.48 ± 36.57, respectively), and total lesions (67.50 ± 44.59 and 70.12 ± 46.83, respectively). The incidence of a burning sensation was significantly greater in the adapalene-BPO group than the adapalene-clindamycin group (32% vs. 6%; P = 0.002). Conclusion: Topical adapalene plus clindamycin and adapalene plus BPO had similar efficacies in the treatment of acne. Adapalene with clindamycin was better tolerated than adapalene with BPO.

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Section: Discussionmentioning

confidence: 83%

Efficacy and tolerability of 0.1% adapalene with 1% clindamycin versus 0.1% adapalene with 2.5% benzoyl peroxide in the treatment of acne vulgaris

Inbamani¹,

Manickam²,

Gopalan

2023

International Journal of Dermatology and Venereology

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“…They found better reductions in inflammatory and noninflammatory lesions, mean acne severity score, and adverse events with the nanoemulsion topical gel compared with the conventional gel. 41 In another similar study, Sabouri et al reported better improving effects of tretinoin loaded nanoemulsion on the number of acne lesions as well as the size and intensity of porphyrin production in a pilot study. 42 Our nanopreparation was safe and tolerable.…”

Section: Resultsmentioning

confidence: 90%

Preparation and evaluation of adapalene nanostructured lipid carriers for targeted drug delivery in acne

Nasrollahi

Koohestani

Naeimifar

et al. 2021

Dermatologic Therapy

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Adapalene (ADA) is believed to be one of the topical treatments utilized commonly in case of acne. Nanostructured lipid carriers (NLCs) have been established as an effective carrier system with certain advantages, for instance increased solubility, drug targeting, controlled drug release, and stability of ADA. This study was conducted to obtain the formulation with a good therapeutic property. All formulations were formed by probe sonicator and its characterizations were analyzed. Finally, the therapeutic effects of 0.1% ADA-loaded nanostructured lipid carriers (NLC-ADA) were evaluated. This formulation had a great entrapment efficiency (EE) that illustrated a controlled drug release profile. A pilot clinical evaluation conducted on 15 patients (age 25.23 ± 12.24 years) with mild to moderate acne vulgaris lesions. The results demonstrated significant reduction in acne severity index and the number of inflammatory and noninflammatory lesions after 12 weeks of treatment (P-value .02, .04, and .01, respectively). Subjective results were confirmed with significant improvement in size and intensity of porphyrin production in pilosebaceous follicles (P-value = .03). The study demonstrated that the formulation was safe and revealed the proper improvement rate of acne lesions after 12 weeks.

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“…This might be explained by the fact that all the clinical isolates used in the study were resistant to clindamycin from the beginning, and drug encapsulated nanoemulsions can be used for enhancement of antibacterial activity only, if already present [14], and possibly our formulated clindamycin nanobiotic could not effectively penetrate the matrix of the tested staphylococcal biofilms for reaching their cellular targets. However, Prasad et al (2012) [43] reported that a gel formulation of clindamycin, prepared as nanoemulsion for topical application, was more effective in improving and alleviating both inflammatory and noninflammatory skin lesions than the conventional clindamycin. In vitro and clinical studies have shown that the topical nanoformulation can improve the penetration of active ingredients into the epidermis and dermis which make clindamycin conjugated nanoemulsion very effective when used topically [43].…”

Section: Discussionmentioning

confidence: 99%

“…However, Prasad et al (2012) [43] reported that a gel formulation of clindamycin, prepared as nanoemulsion for topical application, was more effective in improving and alleviating both inflammatory and noninflammatory skin lesions than the conventional clindamycin. In vitro and clinical studies have shown that the topical nanoformulation can improve the penetration of active ingredients into the epidermis and dermis which make clindamycin conjugated nanoemulsion very effective when used topically [43].…”

Section: Discussionmentioning

confidence: 99%

In Vitro Evaluation of Antimicrobial Activity and Cytotoxicity of Different Nanobiotics Targeting Multidrug Resistant and Biofilm Forming Staphylococci

Mohamed

Nasr

Elkhatib

et al. 2018

BioMed Research International

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Antibiotic-resistant and biofilm-forming bacteria have surprisingly increased over recent years. On the contrary, the rate of development of new antibiotics to treat these emerging superbugs is very slow. Therefore, the aim of this study was to prepare novel nanobiotic formulations to improve the antimicrobial activity of three antibiotics (linezolid, doxycycline, and clindamycin) against Staphylococci. Antibiotics were formulated as nanoemulsions and evaluated for their antimicrobial activities and cytotoxicities. Cytotoxicity of the conventional antibiotics and nanobiotics was analyzed using 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide (MTT) assay on rat hepatocytes. Half-maximal inhibitory concentration (IC50) was estimated from an experimentally derived dose-response curve for each concentration using GraphPad Prism software. Upon quantitative assessment of Staphylococcus biofilm formation, eighty-four isolates (66.14 %) were biofilm forming. Linezolid and doxycycline nanobiotics exhibited promising antibacterial activities. On the contrary, clindamycin nanobiotic exhibited poor antibacterial activity. Minimum biofilm inhibitory concentrations showed that 73.68 %, 45.6%, and 5.2% of isolates were sensitive to linezolid, doxycycline, and clindamycin nanobiotics, respectively. Results of this study revealed that antibiotics loaded in nanosystems had a higher antimicrobial activity and lower cytotoxicities as compared to those of conventional free antibiotics, indicating their potential therapeutic values.

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Efficacy and safety of a nano-emulsion gel formulation of adapalene 0.1% and clindamycin 1% combination in acne vulgaris: A randomized, open label, active-controlled, multicentric, phase IV clinical trial

Cited by 28 publications

References 18 publications

Efficacy and tolerability of 0.1% adapalene with 1% clindamycin versus 0.1% adapalene with 2.5% benzoyl peroxide in the treatment of acne vulgaris

Efficacy and tolerability of 0.1% adapalene with 1% clindamycin versus 0.1% adapalene with 2.5% benzoyl peroxide in the treatment of acne vulgaris

Preparation and evaluation of adapalene nanostructured lipid carriers for targeted drug delivery in acne

In Vitro Evaluation of Antimicrobial Activity and Cytotoxicity of Different Nanobiotics Targeting Multidrug Resistant and Biofilm Forming Staphylococci

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