Aloe Vera 0.5% | Pracasil 30gm (Keloid)
Aloe Vera 0.5% | Pracasil 30gm (Keloid) is a dermatology-focused preparation for prescriber-directed skin protocols. Ingredient selection should reflect the patient's diagnosis, skin type, tolerability, pregnancy status, and treatment goal.
This is a compounded topical scar management preparation containing Aloe Vera 0.5% incorporated into a 30 g PracaSil-Plus base, prepared by Genesis Compounding as a patient-specific, prescriber-directed 503A preparation for the management of keloid and hypertrophic scars. PracaSil-Plus is a specialized anhydrous silicone-pracaxi oil compounding base with documented scar-modifying properties; aloe vera contributes additional anti-inflammatory and wound-healing support. This preparation is not FDA-approved as a compounded preparation.
| Active Ingredient | Pharmacologic Role |
|---|---|
| Aloe Vera 0.5% | Botanical extract providing anti-inflammatory (inhibits prostaglandin and bradykinin synthesis), antioxidant, and wound-healing properties via polysaccharide (acemannan) and glycoprotein components that support collagen synthesis modulation and epithelial repair. |
| PracaSil-Plus base (30 g) | Proprietary anhydrous compounding base combining a semipermeable silicone polymer network with pracaxi oil (rich in behenic and lignoceric fatty acids); creates an occlusive, moisture-retaining barrier over scar tissue that inhibits collagen overproduction, reduces vascularity, and softens and flattens hypertrophic and keloid scars — mechanisms consistent with established silicone-based scar therapy. |
Applied topically to the keloid or hypertrophic scar site.
- Apply a thin layer and massage gently into the scar tissue twice daily (morning and evening).
- Apply to clean, dry skin; the anhydrous silicone base does not require prior moisturization of the site.
- Do not apply to open wounds or incompletely healed incisions.
- Can be used under occlusive dressing if directed by the prescriber, which may enhance silicone hydration effect.
- Consistent twice-daily use is essential; scar remodeling is a slow process requiring weeks to months of therapy.
For silicone-based scar therapy:
- Apply twice daily continuously for a minimum of 2–3 months; clinical improvement in scar height, color, and texture may require 3–6 months of consistent use.
- Regular prescriber reassessment of scar response is recommended.
- May be combined with other scar modalities (compression, intralesional corticosteroids, pulsed-dye laser) at the prescriber's direction.
- Final dosing duration and interval are prescriber-determined.
- Aloe Vera: Acemannan (a β-1,4-mannan polysaccharide) and aloe glycoproteins modulate fibroblast activity, reducing excessive collagen deposition; polyphenols act as antioxidants; prostaglandin and bradykinin inhibition contributes to anti-inflammatory effects relevant to the pruritus and erythema of hypertrophic and keloid scars.
- PracaSil-Plus (Silicone base): The semipermeable silicone polymer network creates a hydrating, occlusive micro-environment over scar tissue. This increases stratum corneum hydration and reduces transepidermal water loss, which — via mechanisms involving fibroblast hydration state — downregulates TGF-β2-mediated collagen overproduction. Pracaxi oil fatty acids (behenic and lignoceric acids) provide additional skin barrier support and anti-inflammatory fatty acid activity.
This preparation is intended for the topical management of keloid and hypertrophic scars, which are characterized by excess collagen deposition beyond the original wound margins (keloid) or within margins (hypertrophic scar). Clinical evidence for silicone-based scar therapy:
- Topical silicone gel and sheeting are recognized as first-line non-invasive interventions for keloid and hypertrophic scar management by dermatology and plastic surgery guidelines.
- PracaSil-Plus has demonstrated reduction in all key scar parameters including pain, itching, color, stiffness, thickness, and irregularity in clinical observations.
- Aloe vera provides complementary anti-inflammatory and fibroblast-modulating support.
Monitoring: Clinical scar assessment (Vancouver Scar Scale or similar) at 6–8 week intervals during treatment. If scar is non-responsive after 3–4 months, consider adjunctive or alternative treatments (intralesional triamcinolone, cryotherapy, laser).
Contraindications:
- Hypersensitivity to aloe vera, silicone polymers, or pracaxi oil.
- Do not apply to open wounds, actively infected skin, or incompletely healed surgical sites.
Warnings & Precautions:
- Keloid scars have a high recurrence potential; topical therapy reduces but may not eliminate recurrence, particularly in genetically predisposed individuals.
- Some patients may develop contact allergy to aloe vera; discontinue if allergic contact dermatitis occurs.
Drug Interactions:
- No significant topical drug interactions are anticipated. Avoid applying other active topical agents (corticosteroids, retinoids) to the same site without prescriber guidance.
Common Side Effects: Generally well-tolerated. Mild local erythema, pruritus, or skin softening at the application site; rare contact allergy to aloe constituents.
Store at room temperature (15–25°C), away from direct heat and sunlight. PracaSil-Plus is an anhydrous base — keep tightly sealed to prevent contamination. Keep out of reach of children. Use before the beyond-use date assigned by Genesis Compounding per USP <795>. Do not freeze.
What is PracaSil-Plus and why is it used for keloids?
PracaSil-Plus is a specialized compounding base combining silicone polymers and pracaxi oil. Silicone-based therapies are the evidence-supported, first-line non-invasive treatment for keloid and hypertrophic scars. The base creates an occlusive micro-environment that hydrates scar tissue and downregulates the excessive collagen-producing signals (TGF-β2) responsible for keloid formation.
How long do I need to use this before seeing results?
Scar remodeling is a slow biological process. Improvement in scar softness, height, and color typically begins at 6–8 weeks of consistent twice-daily use, with continued improvement over 3–6 months. Consistent daily use is essential — sporadic application significantly reduces efficacy.
Can I use this on a fresh scar?
Apply only to fully healed, closed skin. Do not use on open wounds, suture lines that are not fully closed, or actively infected areas. Your prescriber will advise when to begin scar therapy after wound closure.
Is this preparation FDA-approved?
No. This is a patient-specific, 503A compounded preparation from Genesis Compounding. PracaSil-Plus is a proprietary compounding base; the completed preparation is not an FDA-approved finished drug product.
Can this preparation be used under a compression bandage?
In some cases, the prescriber may recommend applying under pressure/occlusive dressings to enhance the hydration effect of the silicone base. Follow your prescriber's specific instructions for combined therapy.
Clinical References
Authoritative sources reviewed in preparing this clinical summary. Provided for prescriber reference; not a substitute for the prescriber’s clinical judgment.