Beclomethasone Dipropionate
| Evidence Level: L3 | Predicted Indications: 10 |
Table of Contents
- Beclomethasone Dipropionate
- Beclomethasone dipropionate: From Asthma and Allergic Rhinitis to Atopic Eczema
Beclomethasone dipropionate: From Asthma and Allergic Rhinitis to Atopic Eczema
One-Sentence Summary
Beclomethasone dipropionate is an inhaled and intranasal corticosteroid, originally used for asthma, allergic rhinitis and nasal polyps. The TxGNN model predicts it may be effective for atopic eczema, but there are no registered clinical trials and only 9 publications, mostly older, small or safety-focused studies. The evidence is therefore limited and should be treated as a research question rather than a confirmed new use.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Asthma, allergic rhinitis, vasomotor rhinitis, nasal cavity polyp (from the knowledge graph; no approved-indication text in the Singapore licence records) |
| Predicted New Indication | Atopic eczema |
| TxGNN Prediction Score | 99.41% |
| Evidence Level | L3 |
| Singapore Market Status | ✓ Marketed |
| Number of Registrations | 5 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism of action data is not available. Based on known information, beclomethasone dipropionate is a corticosteroid with anti-inflammatory and immunosuppressive activity. Its efficacy in allergic airway disease is established, and mechanistically it may be applicable to atopic eczema.
Allergic rhinitis, asthma and atopic dermatitis are closely linked allergic (atopic) conditions that often occur together. Topical corticosteroids are standard therapy for atopic dermatitis, so the prediction is biologically plausible.
There are caveats. The available studies are small and old, and mainly concern oral or topical use in children and systemic absorption with adrenal suppression. One in vitro study reported that topical steroids enhanced spontaneous IgE production in atopic dermatitis patients.
Other predicted indications are weaker. Bronchitis (score 98.68%, L3) is largely an extension of the existing asthma and respiratory use. Several "polyp" predictions (vocal cord, fibroepithelial, uterine, ureter) appear to be driven by the shared "polyp" term and have no clinical evidence.
Clinical Trial Evidence
Currently no related clinical trials registered for atopic eczema.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 1476023 | 1992 | Clinical study | Acta Derm Venereol Suppl | Oral beclomethasone in 14 children with difficult atopic dermatitis: stable control in 10/14 at about 1000 µg/day, but with evidence of slowed linear growth and adrenal effects |
| 14522624 | 2003 | Clinical study | J Dermatol Treat | Short-term growth and bone turnover in 8 children using steroid wet-wrap dressings for atopic eczema |
| 8765824 | 1996 | In vitro / mechanistic | J Allergy Clin Immunol | Topical steroids enhanced in vitro spontaneous IgE production in atopic dermatitis patients |
| 30911861 | 2019 | Preclinical | AAPS PharmSciTech | Beclomethasone micelles in a hydrogel tested in an animal dermatitis model |
| 374799 | 1979 | Clinical study | Nihon Hifuka Gakkai Zasshi | Systemic effects of topical beclomethasone compared with betamethasone valerate and fluocinonide |
| 19571596 | 2009 | Review | Neuroimmunomodulation | Intranasal corticosteroids and adrenal suppression in allergic disease |
| 11488426 | 2001 | Review | Jpn J Pharmacol | Overview of drugs for allergic diseases, including beclomethasone |
| 14616123 | 2003 | Review / case-based | Allergy | Corticosteroid allergy in asthma patients |
| 7813169 | 1994 | Review | Clin Ter | Allergy treatment in pregnancy |
Singapore Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| SIN03597P | CLENIL 50 mcg Pressurised Inhalation Solution | Aerosol, metered | Not stated in the licence record |
| SIN08674P | BECLOMET EASYHALER 200 mcg/inhalation dose | Powder, metered | Not stated in the licence record |
| SIN12634P | BECLO-ASMA CFC-Free Inhaler 50 mcg | Aerosol, metered | Not stated in the licence record |
| SIN10521P | DECOMIT Nasal Spray 50 mcg/actuation | Spray | Not stated in the licence record |
| SIN03941P | CANDID-B Cream | Cream | Not stated in the licence record |
Safety Considerations
- Disease-related cautions (knowledge graph, not label text): Caution is flagged in liver disease, gallbladder disease, adrenocortical insufficiency/Addison disease, ocular hypertension and glaucoma, and in infections (measles, varicella zoster, herpes simplex keratitis, fungal, dermatophyte, parasitic, mycobacterial/leprosy and other infectious diseases). Respiratory and nasal tract diseases are also listed.
- Drug Interactions: 49 interactions were recorded. The only Major one in the listed entries is desmopressin. Moderate interactions include acetazolamide, loop and thiazide diuretics (furosemide, bumetanide, hydrochlorothiazide, chlorthalidone), amphotericin B formulations, foscarnet, capreomycin and cisplatin. Minor interactions include the beta-agonists salbutamol, formoterol and arformoterol.
- Literature safety signals: Systemic absorption, adrenal suppression and slowed growth in children were reported with oral, topical and intranasal use.
Please refer to the package insert for full warnings and contraindications, as these were not available for this report.
Conclusion and Next Steps
Decision: Hold
Rationale: The mechanism is plausible, since corticosteroids are established therapy for atopic dermatitis. However, there are no registered clinical trials, and the literature is small, old and focused mainly on safety (adrenal suppression, growth effects in children). Many established topical corticosteroids already exist for atopic eczema, so the added value of beclomethasone is unclear.
To proceed, the following is needed:
- Package insert warnings and contraindications from the HSA (a blocking gap for safety screening)
- Detailed mechanism of action data
- Controlled efficacy data for beclomethasone in atopic eczema versus existing topical corticosteroids
- A suitable topical formulation and route assessment (the Singapore topical product, a cream, has no stated indication in the licence record)
- A safety plan for children, covering adrenal suppression and growth monitoring
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.