Introduction

Fluocinolone acetonide shampoo (containing 0.01% FA) was developed as an alternative to non-aqueous solutions for enhanced delivery to the affected scalp regions.

Aim

To evaluate the efficacy and safety of fluocinolone acetonide 0.01% shampoo (FS Shampoo) versus its vehicle (shampoo base) in treating seborrhoeic dermatitis of the scalp.

Patient Profile

Patients with seborrheic dermatitis of scalp

Methods

• Multicentre, randomized, double-blind, comparative, vehicle-controlled study
• 100 Patients were divided into two groups Active and placebo
• Patients were treated with FA shampoo or vehicle for 14 days applied for 5 min daily
• The efficacy of the treatment was assessed based on improvements in parameters including erythema, scaling, and pruritus.
• Evaluations were conducted using an eight-point scale ranging from 0 to 3.5, with increments of 0.5, where 0 indicates no symptoms, 1.0 denotes mild severity, 2.0 signifies moderate severity, and 3.0 represents severe severity.
• The global assessment of treatment efficacy was determined by analysing the degree of improvement from the initial evaluation to the 1- to 2-week of treatment, utilizing a six-point scale where 1 indicates full clearance (100%), 2 represents marked improvement (75-99%), 4 signifies fair improvement (<50%), 5 denotes no change, and 6 indicates exacerbation.

Results

• On day 14, patients treated with FA shampoo showed 80% improvement in erythema and those treated with vehicle showed 43% improvement (P < 0.001)
• Patients treated with FA shampoo exhibited a 76% improvement in scaling, whereas those receiving the vehicle treatment showed a 44% improvement, with a statistically significant difference (P < 0.001).
• Improvement in pruritus among patients treated with FA shampoo was 82% vs 68% improvement observed in the vehicle-treated group, with this difference also being statistically significant (P = 0.004).

Figure 1: Evaluations in erythema, pruritus and scaling

• After 14 days of treatment, physicians' global assessments revealed that 84% of patients treated with FA shampoo experienced a significant improvement of 75% to 99% or achieved complete clearance (100%), while only 28% of those receiving vehicle treatment saw similar results.

Table 2: Global Assessment

P<0.001

• No adverse reactions, intolerance or side effects and atrophy cases were reported

Conclusion

• Fluocinolone acetonide shampoo is significantly superior to its vehicle for the treatment of patients with seborrhoeic dermatitis of the scalp
• Despite its brief application period, fluocinolone acetonide shampoo demonstrated significant therapeutic efficacy and excellent tolerability and ease of use. It is clearly a good treatment choice for seborrhoeic dermatitis of the scalp

Reference

J Dermatol Treat 1993; 4:135:137