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:

  1. Can be applied in the morning without causing photosensitivity
  2. 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
  3. Topical Dapsone retains the anti-inflammatory properties of oral Dapsone while reducing the risk of toxicity associated with systemic exposure
  4. Dapsocare does not cause any significant side effects other than mild dryness, peeling, and burning sensation
  5. Dapsocare does not require determining the level of G6PD enzyme or blood tests during controls



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.




Domina Pharmaceuticals
P.O. Box : 9622
Damascus - Syria


Email: info@dominapharm.com
Phone: +963 (11) 33 192 32
Phone: +963 (11) 33 201 04
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