Use of coenzyme Q10 formulations in the treatment and prevention of epidermolysis bullosa
Inventors
Narain, Niven Rajin • Sarangarajan, Rangaprasad • Kiebish, Michael Andrew
Assignees
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Publication Number
US-11419830-B2
Publication Date
2022-08-23
Expiration Date
Abstract
The present invention is directed, in part, to methods of treating Epidermolysis Bullosa (EB) in a subject in need thereof, comprising topical administration of a pharmaceutical composition comprising a therapeutically effective amount of a of Coenzyme Q10 (CoQ10) to the subject.
Core Innovation
The invention is directed to a method of treating Epidermolysis Bullosa (EB) in a subject having one or more wounds associated with EB by topically administering a pharmaceutical composition comprising Coenzyme Q10 (CoQ10). The method targets wounds within a specified size range and uses a CoQ10 dosage of at least 0.01 mg/cm2 to reduce the size of the EB-associated wounds. The claimed approach encompasses EB including EB subtypes.
The problem addressed is impaired wound healing in EB, including prolonged inflammation, and associated defects in structural or functional proteins involved in skin integrity, such as keratins, collagens, plectin, laminins, and integrins. The description connects these impairments to the persistence of EB wounds and associated complications, and proposes that CoQ10 modulates protein expression and wound healing progression. The rationale includes transitioning wounds from an inflammation phase to a proliferative/remodeling phase.
The described embodiments further report topical CoQ10 composition formats and quantitative outcomes, including improvement in wound closure and skin integrity and reductions in pain, inflammation, infections, and scarring. The document also describes potential prevention or treatment of cutaneous squamous cell carcinoma associated with EB, including mechanistic discussion of structural protein changes and anti-SCC activity.
Claims Coverage
The disclosed claim set centers on one independent claim with multiple dependent claims refining the treated indication, composition, dosage constraints, and specific treatment outcomes and effect measures. Overall, the inventive coverage is anchored in topical administration of a CoQ10-containing pharmaceutical composition at a minimum per-area CoQ10 dosage to reduce EB wound size, with dependent features specifying time, extent of wound reduction, and additional clinical and biological effects.
Topical CoQ10 pharmaceutical composition for EB wound size reduction
A method of treating Epidermolysis Bullosa (EB) in a subject having one or more wounds associated with the EB by topically administering a pharmaceutical composition comprising Coenzyme Q10 (CoQ10) at a dosage of CoQ10 of at least 0.01 mg/cm2, thereby reducing the size of the one or more wounds associated with the EB.
EB wound size limitation and treated wound area range
The method of treating EB is applied to a subject having one or more wounds associated with the EB between 2.5 cm2 and 50 cm2 in size.
About four weeks treatment with at least about 70% wound size reduction
The method includes treating with an effective amount of CoQ10 for about four weeks, resulting in at least about a 70% reduction in the size of one or more wounds.
CoQ10 cream dosage between 0.01 mg/cm2 and 5 mg/cm2
The method includes administering a pharmaceutical composition containing CoQ10 as a CoQ10 cream at a CoQ10 dosage between 0.01 mg/cm2 and 5 mg/cm2.
CoQ10 content in about 1% to about 5% w/w
The method includes a pharmaceutical composition in which the CoQ10 content is within about 1% to about 5% by weight (w/w).
Treatment of specific EB subtypes
The method is applied to Epidermolysis Bullosa Simplex, Junctional Epidermolysis Bullosa, Dystrophic Epidermolysis Bullosa, or Kindler's Syndrome.
Additional EB benefits including pain, inflammation, healing, skin integrity, infections, scarring, and increased keratinocyte/fibroblast production
The method includes administering a CoQ10-containing pharmaceutical composition resulting in beneficial effects related to epidermolysis bullosa (EB) including reduced pain and inflammation, improved wound healing and closure, improved skin integrity with fewer infections and less scarring, reduced need for concomitant medications, and increased keratinocyte and fibroblast production.
Across the claim coverage, the inventive core is the topical administration of a CoQ10-containing pharmaceutical composition at a minimum per-area CoQ10 dosage to reduce EB-associated wound size within a defined wound area range. Dependent claims further specify treatment duration with a threshold level of wound-size reduction, constrain CoQ10 cream form and per-area dosing, define CoQ10 content as about 1% to about 5% w/w, limit the EB indication to specified EB subtypes, and claim additional EB-related beneficial effects encompassing pain and inflammation reduction, improved healing and skin integrity, fewer infections and less scarring, reduced concomitant medication use, and increased keratinocyte and fibroblast production.
Stated Advantages
Reducing the size of one or more EB-associated wounds.
Reducing pain and inflammation associated with EB.
Improving wound healing and closure, including re-epithelization and granulation.
Improving skin integrity with fewer infections and less scarring.
Reducing the need for concomitant medications.
Increasing keratinocyte production and fibroblast production.
Documented Applications
Treating Epidermolysis Bullosa, including EB subtypes, in a subject with one or more EB-associated wounds by topical administration of a CoQ10 pharmaceutical composition to reduce wound size.
Potential prevention or treatment of cutaneous squamous cell carcinoma associated with EB is described in the document.
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