A Prospective, Randomized, Comparative Study of Topical Minocycline Gel 4% with Topical Clindamycin Phosphate Gel 1% in Indian Patients with Acne Vulgaris
Abstract
:1. Introduction
2. Results
2.1. Patient Disposition
2.2. Demographic and Disease Characteristics at Baseline
2.3. Efficacy Analysis
2.4. Efficacy among Young Adults and Adolescents
2.5. Safety and Tolerability Assessment
3. Discussion
4. Materials and Methods
4.1. Study Design
4.2. Participant’s Eligibility Criteria
4.3. Drug Administration
4.4. Efficacy and Safety Endpoints
4.5. Statistical Methods
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Characteristics | Treatment | p-Value | ||
---|---|---|---|---|
Topical Minocycline | Topical Clindamycin | |||
4% Gel (N = 50) | 1% Gel (N = 50) | |||
Age (years) 1 | 19.76 ± 4.38; 18.0; (14, 31) | 20.58 ± 4.59; 20.0; {14, 32) | 0.363 † | |
Gender 2 | Male | 18 (36.0) | 16 (32) | 0.673 * |
Female | 32 (64.0) | 34 (68) | ||
Grade of acne 2 | 1 | 10 (20.0) | 18 (36.0) | 0.069 * |
2 | 31 (62.0) | 29 (58.0) | ||
3 | 9 (18.0) | 3 (6.0) | ||
Duration of acne (months) 1 | 12.24 ± 13.63; 7.00; (1, 60) | 8.08 ± 9.91; 4.00; (1, 48) | 0.084 † | |
Number of inflammatory lesions 1 | 6.22 ± 5.03; 5.00; (0, 20) | 4.32 ± 3.89; 3.00; (0, 15) | 0.066 ‡ | |
Number of non-inflammatory lesions 1 | 14.06 ± 8.22; 12.00; (2, 42) | 12.74 ± 6.21; 12.00; (0, 35) | 0.618 ‡ | |
Investigator’s global score 1 | 2.64 ± 0.9; 3.00; (1, 5) | 2.44 ± 1.15; 2.00; (1, 9) | 0.059 ‡ |
Parameter | Visit | Treatment | p-Value 2 | |||||||
---|---|---|---|---|---|---|---|---|---|---|
Topical Minocycline | Topical Clindamycin | |||||||||
4% Gel (N = 50) | 1% Gel (N = 50) | |||||||||
n | Mean | SD | Median | n | Mean | SD | Median | |||
Number of inflammatory lesions | Baseline | 50 | 6.22 | 5.03 | 5 | 50 | 4.32 | 3.89 | 3 | 0.066 |
Week 3 | 50 | 4.54 | 4.36 | 4 | 50 | 4.48 | 3.59 | 4 | 0.7 | |
Week 6 | 50 | 2.8 | 3.02 | 2 | 50 | 3.36 | 2.96 | 3 | 0.221 | |
Week 9 | 49 | 1.8 | 2.26 | 1 | 49 | 2.71 | 2.61 | 2 | 0.047 | |
Week 12 | 46 | 0.98 | 1.51 | 0 | 45 | 1.69 | 1.84 | 1 | 0.038 | |
p-value 1 | <0.0001 | <0.0001 | ||||||||
Number of non-inflammatory lesions | Baseline | 50 | 14.06 | 8.22 | 12 | 50 | 12.74 | 6.21 | 12 | 0.618 |
Week 3 | 50 | 10.42 | 6.27 | 10 | 50 | 10.8 | 4.9 | 10 | 0.274 | |
Week 6 | 50 | 7.52 | 5.1 | 7 | 50 | 9.26 | 4.21 | 8 | 0.01 | |
Week 9 | 49 | 4.39 | 3.7 | 4 | 49 | 6.69 | 3.7 | 6 | 0.001 | |
Week 12 | 46 | 2.07 | 2.45 | 1.5 | 45 | 4.49 | 2.84 | 4 | <0.0001 | |
p-value 1 | <0.0001 | <0.0001 |
Parameter | Visit | Treatment | p-Value 2 | |||||||
---|---|---|---|---|---|---|---|---|---|---|
Topical Minocycline | Topical Clindamycin | |||||||||
4% Gel (N = 50) | 1% Gel (N = 50) | |||||||||
n | Mean | SD | Median | n | Mean | SD | Median | |||
Investigator’s global assessment score | Baseline | 50 | 2.64 | 0.9 | 3 | 50 | 2.44 | 1.15 | 2 | 0.059 |
Week 3 | 50 | 2.20 | 0.86 | 2 | 50 | 2.26 | 0.56 | 2 | 0.808 | |
Week 6 | 50 | 1.76 | 0.85 | 2 | 50 | 2.02 | 0.59 | 2 | 0.080 | |
Week 9 | 49 | 1.22 | 0.65 | 1 | 49 | 1.71 | 0.65 | 2 | 0.001 | |
Week 12 | 46 | 0.74 | 0.71 | 1 | 45 | 1.02 | 0.87 | 1 | 0.113 | |
p-value 1 | <0.0001 | <0.0001 | ||||||||
Investigator’s Global Assessment—Treatment success at (YES) | n (%) | n (%) | p-value 3 | |||||||
Week 3 | 0 (0) | 0 (0) | - | |||||||
Week 6 | 4 (8.0) | 0 (0) | 0.126 | |||||||
Week 9 | 15 (30.6) | 2 (4.1) | 0.001 | |||||||
Week 12 | 34 (73.9) | 21 (46.7) | 0.015 |
Change from Baseline to 12 Months | Treatment | p-Value *,1 (Young Adult) | p-Value *,2 (Adolescent) | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Topical Minocycline 4% Gel | Topical Clindamycin 1% Gel | |||||||||||||||
Age > 19 (Young Adult) | Age ≤ 19 (Adolescent) | p-Value * | Age > 19 (Young Adult) | Age ≤ 19 (Adolescent) | p-Value * | |||||||||||
n | Mean | SD | n | Mean | SD | n | Mean | SD | n | Mean | SD | |||||
% reduction in inflammatory lesions | 20 | 88.24 | 13.89 | 26 | 88.71 | 14.47 | 0.988 | 24 | 66.90 | 36.41 | 21 | 64.60 | 30.54 | 0.645 | 0.086 | 0.004 |
% reduction in non-inflammatory lesions | 20 | 87.30 | 14.59 | 26 | 88.32 | 10.35 | 0.899 | 24 | 65.00 | 21.16 | 21 | 61.91 | 21.10 | 0.697 | 0.001 | <0.0001 |
IGA score | 20 | 1.90 | 0.64 | 26 | 1.92 | 0.84 | 0.797 | 24 | 1.17 | 0.92 | 21 | 1.71 | 1.59 | 0.383 | 0.001 | 0.037 |
Tolerability Assessment Parameter | Visit | Topical Minocycline 4% Gel (N = 50) | Topical Clindamycin 1% Gel (N = 50) | p-Value | ||||||
---|---|---|---|---|---|---|---|---|---|---|
None | Mild | Moderate | Intense | None | Mild | Moderate | Intense | |||
Erythema | Week 3 | 40 | 9 | 1 | 0 | 32 | 17 | 1 | 0 | 0.187 |
Week 6 | 47 | 3 | 0 | 0 | 43 | 7 | 0 | 0 | 0.317 | |
Week 9 | 47 | 2 | 0 | 0 | 40 | 9 | 0 | 0 | 0.055 | |
Week 12 | 46 | 0 | 0 | 0 | 40 | 5 | 0 | 0 | 0.062 | |
Dryness | Week 3 | 44 | 6 | 0 | 0 | 30 | 19 | 1 | 0 | 0.005 |
Week 6 | 47 | 3 | 0 | 0 | 31 | 19 | 0 | 0 | <0.0001 | |
Week 9 | 45 | 4 | 0 | 0 | 35 | 14 | 0 | 0 | 0.019 | |
Week 12 | 40 | 6 | 0 | 0 | 22 | 23 | 0 | 0 | <0.0001 | |
Hyperpigmentation | Week 3 | 50 | 0 | 0 | 0 | 50 | 0 | 0 | 0 | - |
Week 6 | 49 | 1 | 0 | 0 | 50 | 0 | 0 | 0 | 0.999 | |
Week 9 | 45 | 4 | 0 | 0 | 49 | 0 | 0 | 0 | 0.126 | |
Week 12 | 44 | 2 | 0 | 0 | 45 | 0 | 0 | 0 | 0.484 | |
Skin peeling | Week 3 | 44 | 6 | 0 | 0 | 38 | 12 | 0 | 0 | 0.193 |
Week 6 | 45 | 5 | 0 | 0 | 34 | 16 | 0 | 0 | 0.014 | |
Week 9 | 43 | 5 | 1 | 0 | 38 | 11 | 0 | 0 | 0.169 | |
Week 12 | 45 | 1 | 0 | 0 | 38 | 7 | 0 | 0 | 0.060 | |
Itching | Week 3 | 36 | 13 | 1 | 0 | 33 | 16 | 1 | 0 | 0.802 |
Week 6 | 42 | 8 | 0 | 0 | 41 | 9 | 0 | 0 | 0.999 | |
Week 9 | 49 | 0 | 0 | 0 | 36 | 13 | 0 | 0 | <0.0001 | |
Week 12 | 44 | 2 | 0 | 0 | 30 | 15 | 0 | 0 | 0.001 |
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Shah, B.; Mistry, D.; Gonsalves, N.; Vasani, P.; Dhoot, D.; Barkate, H. A Prospective, Randomized, Comparative Study of Topical Minocycline Gel 4% with Topical Clindamycin Phosphate Gel 1% in Indian Patients with Acne Vulgaris. Antibiotics 2023, 12, 1455. https://doi.org/10.3390/antibiotics12091455
Shah B, Mistry D, Gonsalves N, Vasani P, Dhoot D, Barkate H. A Prospective, Randomized, Comparative Study of Topical Minocycline Gel 4% with Topical Clindamycin Phosphate Gel 1% in Indian Patients with Acne Vulgaris. Antibiotics. 2023; 12(9):1455. https://doi.org/10.3390/antibiotics12091455
Chicago/Turabian StyleShah, Bela, Deval Mistry, Nelry Gonsalves, Presha Vasani, Dhiraj Dhoot, and Hanmant Barkate. 2023. "A Prospective, Randomized, Comparative Study of Topical Minocycline Gel 4% with Topical Clindamycin Phosphate Gel 1% in Indian Patients with Acne Vulgaris" Antibiotics 12, no. 9: 1455. https://doi.org/10.3390/antibiotics12091455