FDA Approval:
- In 2008, Dapsone 5% gel was FDA approved for twice-daily use for the treatment of acne in people aged 12 years and older
- In 2017, Dapsone 7.5% gel was FDA approved for once daily use for the treatment of acne in people 9 years of age and older
Guideline from Journal of the American Academy of Dermatology:
Topical dapsone gel is recommended for inflammatory acne, particularly in adult females with acne.
Studies on Dapsone 5% gel:
At 12 months after Dapsone 5% gel treatment, mean reduction from baseline was 19.5%, 58.2%, and 49.0% for inflammatory, noninflammatory, and total lesion counts, respectively
Studies on Dapsone 7.5% gel:
At 12 weeks after Dapsone 7.5% gel treatment, a reduction in lesion counts for inflammatory lesions was 54.6% and for noninflammatory lesions was 39.4%
Studies on Dapsone 5% gel and Dapsone 7.5% gel:
- Dapsone monotherapy showed a treatment success rate of 69.4% – 40.1% for Dapsone 5% gel and 47.0% – 29.8% for Dapsone 7.5% gel when used for 16 – 12 weeks
- Both Dapsone 5% and 7.5% gel showed a reduction in inflammatory lesion counts as early as week 2
- In all studies, inflammatory lesions decreased by a larger percentage than noninflammatory or total lesions
- A significantly greater reduction in acne lesion counts was found in female patients following 12 weeks of treatment
- Topical Dapsone 7.5% gel has the benefit of improving patient compliance due to once daily dosing
Benefits of Dapsocare Dermal gel:
- Can be applied in the morning without causing photosensitivity
- Dapsocare offers a safe and promising alternative therapy for patients with difficult to treat acne or those who experience adverse effects to first-line therapies
- Topical Dapsone retains the anti-inflammatory properties of oral Dapsone while reducing the risk of toxicity associated with systemic exposure
- Dapsocare does not cause any significant side effects other than mild dryness, peeling, and burning sensation
- Dapsocare does not require determining the level of G6PD enzyme or blood tests during controls
References:
1. Nickles, M. A. & Lake, E. (2022) Topical dapsone in the treatment of acne: a systematic review.International Journal of Dermatology, 61 (11): 1412-1421.
2. Zaenglein, A. L., Pathy, A. L., Schlosser, B. J., Alikhan, A., Baldwin, H. E., Berson, D. S., Bowe, W. P.,Graber, E. M., Harper, J. C., Kang, S., Keri, J. E., Leyden, J. J., Reynolds, R. V., Silverberg, N. B., Stein Gold, L. F., Tollefson, M. M., Weiss, J. S., Dolan, N. C., Sagan, A. A., Stern, M., Boyer, K. M. & Bhushan, R. (2016) Guidelines of care for the management of acne vulgaris. Journal of the American Academy of Dermatology, 74 (5): 945-973.e933.
3. Lucky, A. W., Maloney, J. M., Roberts, J., Taylor, S., Jones, T., Ling, M., Garrett, S. & Dapsone Gel Long- Term Safety Study, G. (2007) Dapsone %5 gel for the treatment of acne vulgaris: safety and efficacy of long-term (1 year) treatment. Journal of drugs in dermatology, 6 (10): 981.
4. Moore, A. Y., Lain, E. L., McMichael, A., Kircik, L., Zaenglein, A. L., Hebert, A. A. & Grada, A. (2021) Once-daily Dapsone 7.5% Gel for the Treatment of Acne Vulgaris in Preadolescent Patients: A Phase IV, Open-label, 12-week Study. J Clin Aesthet Dermatol, 14 (4): 43-48.
5. Al-Salama, Z. T. & Deeks, E. D. (2017) Dapsone 7.5% Gel: A Review in Acne Vulgaris. American journal of clinical dermatology, 18 (1): 139-145.
6. Temiz, S. A. & Daye, M. (2022) Dapsone for the treatment of acne vulgaris: do the risks outweigh the benefits? Cutan Ocul Toxicol, 41 (1): 60-66.
7. Tanghetti, E., Harper, J. C. & Oefelein, M. G. (2012) The efficacy and tolerability of dapsone %5 gel in female vs male patients with facial acne vulgaris: gender as a clinically relevant outcome variable. Journal of drugs in dermatology, 11 (12): 1417.
8. Draelos, Z. D., Carter, E., Maloney, J. M., Elewski, B., Poulin, Y., Lynde, C. & Garrett, S. (2007) Two randomized studies demonstrate the efficacy and safety of dapsone %5 gel for the treatment of acne vulgaris. Journal of the American Academy of Dermatology, 56 (3): 439.e431-439.e410.
9. Thiboutot, D. M., Kircik, L., McMichael, A., Cook-Bolden, F. E., Tyring, S. K., Berk, D. R., Chang-Lin, J. E., Lin, V. & Kaoukhov, A. (2016) Efficacy, Safety, and Dermal Tolerability of Dapsone %7.5 Gel, in Patients with Moderate Acne Vulgaris: A Pooled Analysis of Two Phase3 Trials. J Clin Aesthet Dermatol, 9 (10): 18-27.