Introduction
DIPROLENE AF Cream, containing the active ingredient betamethasone dipropionate, is a high-potency topical corticosteroid used to treat various corticosteroid-responsive dermatoses, including chronic plaque psoriasis and atopic dermatitis. Here, we will delve into the clinical trials, market analysis, and projections for this drug.
Clinical Trials Overview
Efficacy and Safety Trials
The efficacy and safety of DIPROLENE AF Cream have been established through several clinical trials. In two randomized and active controlled trials involving 81 subjects with chronic plaque psoriasis, DIPROLENE AF Cream was applied once or twice daily for 14 and 21 days, respectively. These trials demonstrated the effectiveness of DIPROLENE AF Cream in relieving the signs and symptoms of chronic plaque psoriasis[1][3][4].
Adverse Reactions and Side Effects
In controlled clinical trials involving 242 adult subjects, the most common adverse reaction associated with DIPROLENE AF Cream was stinging, reported in only 1 subject (0.4% frequency)[1][3][4].
In pediatric trials involving 67 subjects from 3 months to 12 years of age, adverse reactions included signs of skin atrophy such as telangiectasia, bruising, and shininess, occurring in 10% of the subjects[1][3][4].
HPA Axis Suppression
A significant concern with high-potency topical corticosteroids like DIPROLENE AF is the potential for hypothalamic-pituitary-adrenal (HPA) axis suppression. In an open-label pediatric trial of 60 subjects, 19 showed evidence of HPA axis suppression. However, 75% of the subjects tested 2 weeks after discontinuation had complete recovery of HPA axis function. The risk of adrenal suppression was found to be progressively greater in younger age groups[1][2][3].
Mechanism of Action and Pharmacodynamics
Mechanism of Action
DIPROLENE AF Cream works through the mechanism of action typical of corticosteroids, involving cellular signaling, immune function, inflammation, and protein regulation. However, the precise mechanism in corticosteroid-responsive dermatoses is not fully understood[1].
Pharmacodynamics
Vasoconstrictor trials have indicated that DIPROLENE AF Cream is in the high range of potency compared to other topical corticosteroids. This potency is demonstrated by its significant vasoconstrictive effects in healthy subjects[1][3][4].
Market Analysis and Projections
Global Topical Corticosteroids Market
The global topical corticosteroids market, which includes DIPROLENE AF, is expected to grow significantly. As of 2021, the market size was estimated at USD 4.85 billion and is projected to reach USD 8.19 billion by 2030, growing at a CAGR of 6% during the forecast period from 2021 to 2030[5].
Market Drivers and Trends
The growth in the topical corticosteroids market is driven by increasing prevalence of skin disorders such as psoriasis, atopic dermatitis, and eczema. Additionally, advancements in formulation technologies and the development of more potent and safer topical corticosteroids contribute to market expansion.
Use in Specific Populations
Pediatric Use
Pediatric patients are at a higher risk of systemic toxicity and HPA axis suppression due to their larger skin surface area to body mass ratio. This makes careful monitoring and dose adjustment crucial when using DIPROLENE AF Cream in pediatric patients[1][2][3].
Geriatric Use
Clinical trials have included subjects aged 65 and over, and no significant differences in safety or effectiveness were observed compared to younger subjects. However, greater sensitivity in some older individuals cannot be ruled out[1].
Precautions and Warnings
Systemic Effects
Rare systemic effects such as Cushing's syndrome, hyperglycemia, linear growth retardation, delayed weight gain, and intracranial hypertension can occur, especially with prolonged exposure to large doses of high-potency topical corticosteroids[1][2][4].
Withdrawal and Substitution
If HPA axis suppression is documented, gradual withdrawal of the drug, reduction in application frequency, or substitution with a less potent corticosteroid is recommended. Signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids[1][2][4].
Key Takeaways
- Efficacy: DIPROLENE AF Cream is effective in treating chronic plaque psoriasis and other corticosteroid-responsive dermatoses.
- Safety: The drug can cause HPA axis suppression, especially in pediatric patients, and other systemic effects with prolonged use.
- Market Growth: The global topical corticosteroids market is expected to grow significantly, driven by increasing prevalence of skin disorders and advancements in formulation technologies.
- Use in Specific Populations: Pediatric patients require careful monitoring due to higher risk of systemic toxicity and HPA axis suppression.
Frequently Asked Questions (FAQs)
Q: What is DIPROLENE AF Cream used for?
A: DIPROLENE AF Cream is used to treat corticosteroid-responsive dermatoses, including chronic plaque psoriasis and atopic dermatitis.
Q: What are the common side effects of DIPROLENE AF Cream?
A: Common side effects include stinging, signs of skin atrophy such as telangiectasia, bruising, and shininess.
Q: Can DIPROLENE AF Cream cause HPA axis suppression?
A: Yes, DIPROLENE AF Cream can cause reversible HPA axis suppression, particularly in pediatric patients.
Q: How is DIPROLENE AF Cream supplied?
A: DIPROLENE AF Cream 0.05% is supplied in 15-g and 50-g tubes.
Q: What is the projected market size for topical corticosteroids by 2030?
A: The global topical corticosteroids market is projected to reach USD 8.19 billion by 2030.
Cited Sources:
- Drugs.com - Diprolene AF: Package Insert / Prescribing Information
- DailyMed - Label: DIPROLENE- betamethasone dipropionate ointment
- RxList - Diprolene AF (Betamethasone): Side Effects, Uses, Dosage
- FDA - DIPROLENE AF Cream - accessdata.fda.gov
- Spherical Insights - Topical Corticosteroids Market Size, Analysis, Forecasts to 2030
