Fluticasone Propionate
| Evidence Level: L5 | Predicted Indications: 10 |
Table of Contents
- Fluticasone Propionate
- Fluticasone Propionate: From Allergic and Inflammatory Conditions to 2-Hydroxyethyl Methacrylate Sensitization
Fluticasone Propionate: From Allergic and Inflammatory Conditions to 2-Hydroxyethyl Methacrylate Sensitization
One-Sentence Summary
Fluticasone propionate is a corticosteroid originally used for allergic and inflammatory conditions of the skin, nose and airways, such as atopic eczema, contact dermatitis, allergic rhinitis and asthma. The TxGNN model predicts it may be effective for 2-hydroxyethyl methacrylate sensitization, but this prediction rests on the model score alone, with 0 clinical trials and 0 publications supporting this specific indication.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Atopic eczema, contact dermatitis, allergic rhinitis, allergic and intrinsic asthma, seborrheic dermatitis, and related conditions (the Singapore licence records contain no indication text) |
| Predicted New Indication | 2-hydroxyethyl methacrylate sensitization |
| TxGNN Prediction Score | 98.56% |
| Evidence Level | L5 |
| Singapore Market Status | ✓ Marketed |
| Number of Registrations | 18 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism of action data is not available in the data compiled for this report. Based on known pharmacology, fluticasone propionate is a synthetic glucocorticoid that binds the glucocorticoid receptor (NR3C2 and PGR binding is also recorded for the mineralocorticoid and progesterone receptors). Activating this receptor suppresses inflammatory cytokines and immune cell activity.
2-hydroxyethyl methacrylate sensitization is an allergic contact sensitization, a type IV (delayed) hypersensitivity reaction. Fluticasone propionate is already used for related allergic conditions, including contact dermatitis, so a mechanistic link is plausible. However, this rationale is inferred from the model prediction only. No trials or literature were found for this specific sensitization, and the drug's similarity to the original indications has not been formally assessed.
Other predictions in the ranking (for context):
- Atopic dermatitis (rank 7, score 95.3%) is already among the drug's original indications, so it validates the model rather than representing true repurposing. It has the strongest supporting data (see below).
- Alopecia areata (rank 5, score 95.9%) has a plausible class-level rationale, as topical and intralesional corticosteroids are established treatments, but no fluticasone-specific evidence was found.
- Alopecia mucinosa (rank 3) and folliculitis decalvans (rank 6) have plausible anti-inflammatory rationales but no evidence.
- Vulvar inverted follicular keratosis, telogen effluvium, vocal cord polyp, and hereditary hypotrichosis with recurrent skin vesicles have weak or no mechanistic rationale.
- Polyp of middle ear (rank 10) has only indirect evidence from nasal polyposis studies.
Clinical Trial Evidence
Currently no related clinical trials registered for 2-hydroxyethyl methacrylate sensitization.
Literature Evidence
Currently no related literature available for 2-hydroxyethyl methacrylate sensitization.
For reference, the data compiled for this report includes evidence for the rank-7 prediction, atopic dermatitis (an existing indication). The five trials are listed below.
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT01915914 | Phase 4 | Completed | 107 | Randomized, open-label study of twice-weekly fluticasone 0.05% cream to reduce relapse in children with stabilized atopic dermatitis |
| NCT00546000 | Phase 4 | Completed | 56 | Open-label study of the effect of Cutivate 0.05% lotion on the HPA axis in infants with atopic dermatitis |
| NCT00616538 | Phase 4 | Completed | 121 | Pilot study of Epiceram barrier cream versus mid-strength topical steroid (fluticasone 0.05%) in paediatric atopic dermatitis |
| NCT03742414 | Phase 2 | Active, not recruiting | 398 | SEAL study of proactive skin care including fluticasone cream to prevent the allergic march in infants |
| NCT07537751 | Not applicable | Completed | 40 | Double-blind comparison of crisaborole 2% versus fluticasone 0.05% in children with mild to moderate atopic dermatitis |
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 14522623 | 2003 | Double-blind comparative studies | J Dermatol Treat | Two multicentre studies of fluticasone 0.05% cream for acute and maintenance treatment of moderate to severe atopic dermatitis in children |
| 12207596 | 2002 | Clinical study | Br J Dermatol | Intermittent dosing of fluticasone cream to reduce relapse risk |
| 21977914 | 2012 | Review | J Eur Acad Dermatol Venereol | Fluticasone has a high therapeutic index for intervention and maintenance treatment of atopic dermatitis |
| 15608497 | 2005 | Review | Skin Pharmacol Physiol | Safety and efficacy of topical fluticasone in skin diseases |
| 11862174 | 2002 | Clinical study | J Am Acad Dermatol | Safety of fluticasone 0.05% cream in severe, extensive atopic dermatitis in children as young as 3 months |
| 18298423 | 2009 | Clinical study | Pediatr Allergy Immunol | Long-term maintenance with 0.005% ointment in 90 children, including sex differences |
| 33150035 | 2020 | Open-label comparative study | Dermatol Pract Concept | Fluticasone versus tacrolimus for proactive treatment of atopic dermatitis |
Singapore Market Information
The licence records contain no approved indication text. Of the 18 valid licences (all single-ingredient entries, none cancelled), the main ones are:
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| SIN08628P | CUTIVATE CREAM 0.05% w/w | Cream | Not recorded |
| SIN07090P | FLIXONASE AQUEOUS NASAL SPRAY 0.05% w/w | Spray | Not recorded |
| SIN11358P | FLIXOTIDE EVOHALER 50 mcg | Aerosol, spray | Not recorded |
| SIN11531P | SERETIDE EVOHALER 25/250 mcg | Aerosol, spray | Not recorded |
| SIN15255P | DYMISTA NASAL SPRAY | Spray, metered | Not recorded |
The drug is available as a topical cream, nasal sprays and inhalers, so route compatibility with any new indication would need to be assessed.
Safety Considerations
Please refer to the package insert for safety information.
Additional information from the knowledge graph (not label text):
- Potential contraindicated conditions: hypertension, long QT syndrome, epilepsy, liver disease, gallbladder disease, hyperglycaemia, measles, herpes simplex virus keratitis, and various pituitary hormone deficiency and hypogonadotropic hypogonadism conditions.
- Receptor binding: besides the glucocorticoid receptor, the drug binds the mineralocorticoid and progesterone receptors.
- Literature signals: the data includes reviews on adrenal (HPA axis) suppression with intranasal corticosteroids and on corticosteroid allergy in asthma patients.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction for 2-hydroxyethyl methacrylate sensitization is supported only by the model score (L5), with no trials or literature. The mechanism is plausible, since topical corticosteroids are used in allergic contact dermatitis, but it is unverified. The package insert safety data is missing.
To proceed, the following is needed:
- Fluticasone-specific clinical or literature evidence for 2-hydroxyethyl methacrylate sensitization, plus a review of class-level corticosteroid data
- Package insert warnings and contraindications from the HSA website
- Detailed mechanism of action data (for example from DrugBank)
- Approved indication text for the Singapore licences
- Assessment of route compatibility (topical versus nasal or inhaled forms) for the target condition
- Consideration of alopecia areata (rank 5), where a class-level rationale exists, as a possible follow-up candidate
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.