Introduction

Acne vulgaris is a common chronic inflammatory condition of the pilosebaceous unit, typically affecting the face, back, and chest, and marked by comedones, papules, pustules, nodules, cysts, and potential scarring.

Aim

To evaluate the safety and efficacy of topical dapsone 5% gel in treating inflammatory acne vulgaris

Patient Profile

• 60 patients diagnosed with grade 1-3 acne vulgaris

Methods

• N=60 patients aged 15- 40 years (mean age: 23.2 years; 78.3% female)
• Intervention: Dapsone 5% gel applied twice daily for 12 weeks
• Follow-ups: At 4, 8, and 12 weeks
• Assessments
  • Efficacy: Investigator Global Assessment (IGA), lesion count reduction ,IGA scoring, including achieving a score of ‘clear’ or ‘almost clear’ with at least two-grade improvement from baseline at 12 weeks, along with mean percentage reduction in lesion count.
  • Safety: Adverse events, CBC, ALT/AST, tolerability (erythema, dryness, scaling, etc.) rated on a 0-3 scale

Results  

• Acne severity reduction
  • Mean total acne score dropped from 14.07 ± 1.81 (week 4) to 3.87 ± 0.69 (week 12)
  • Overall reduction: 90.3 ± 3.38%  (p<0.05)

• Lesion-specific improvements

Statistically significant reductions (p<0.05) were observed in mean acne scores from 2^nd follow up to 3^rd follow up for open comedones (decreased from (2.15+ 0.36) to (1.88+0.28), closed comedones (from (5.91+1.06) to (3.27+ 0.98), papules (from (3.92+1.47) to (2.67+0.92), and pustules (from (2.09+1.09) to (1.04+0.5)

Table 1: Acne score of open comedones, Papule, Pustule

• Investigators’ Global Assessment (IGA) scores showed most patients achieved near clear-to-clear skin by the end of the study.

• The Investigators' Global Assessment (IGA) scores showed a consistent decline over time, with the average score improving from 2.32 at week 4 to 1.45 at week 8, and further to 0.47 by week 12

Table 2 : Evaluation of Investigators Global Assessment (IGA) scale (n=60)

Score	4th week	8th week	12th week
0	3	17	31
1	8	19	17
2	19	9	12
3	30	15	0
4	0	0	0
Mean score	2.32	1.45	0.47

• Safety
  • Mild side effects: scaling (2.20 ± 0.76), dryness (0.63 ± 0.49), erythema (0.47 ± 0.51)
  • No severe adverse events or hematologic toxicity
  • Total safety score improved significantly (p = 0.001)

 

Table 3: Total Safety score in different follow up (n=60)

Total Safety score			Mean ± SD
1st follow up			11.27±1.01
2nd follow up			7.63±0.96
3rd follow up			3.73±1.01
P value			0.001

Table 4: Safety score of Erythema, Burning, Scaling, Dryness and  in 3^rd follow up

Safety score	Mean ± SD
Erythema	0.47±0.51
Burning	0.10±0.31
Scaling	2.20±0.76
Dryness	0.63±0.49
Pruritus	0.33±0.48

Conclusion

Topical Dapsone 5% gel proved to be safe, well-tolerated, and highly effective for inflammatory acne, showing marked clinical improvement with minimal side effects.

Reference

Int. J. Dermatol. Venereology Leprosy Sci. 2025; 8(1): 26-30