Tdah.co.kr

(A Revolutionary Oxygen Therapy)
Pankaj Modi, PhD, MD, FRCM(UK)
Transdermal Corp
Founder and President
Presentation Goals
Acne Therapy and Market Potential
• Acne is a disorder resulting from the action of hormones on the skin's
oil glands (sebaceous glands)
• It leads to plugged pores and outbreaks of lesions commonly called
pimples or zits.
• Acne lesions usually occur on the face, neck, back, chest, and
shoulders.
• Nearly 30 million people in the United States have acne, making it
the most common skin disease.
• People of all races and ages get acne.
• It is most common in adolescents and young adults.
• Nearly 85 percent of people between the ages of 12 and 24 develop
the disorder.
• The total market size for the treatment of skin related problems
exceeds more than 20 billions and growing
• Everyone wants to improve their appearance and look young.
Topical Antibacterial Agents
• Current formulations on the Market today are Harsh on the skin and damaging • Despite their claims, they do not remove Acne and Scars effectively • They contain sulfur and salicylic acid and phenols • They leave white residue on the skin upon drying as these ingredients forms insoluble formulations • They cause irritation, burning and redness • Most formulations leaves skin dry and creates roughness Advantages of Relovox
Formulation
• To quickly provide highest concentration of OXYGEN to kill bacteria and helps unplug the pores • DINs approved by the Health Canada as OTC formulation• (US and World) Patent Protected Technology Micellar Formulation;
Novel Drug Delivery Technology
• This novel delivery system enables insoluble active pharmaceuticals to be solubilized into an aqueous formulation. • The micelle nanotechnology is patented Technology in North America and Europe and pending applications relating to a range of compounds.
• Micelle nanotechnology entraps hydrophobic (water insoluble) drug compounds (e.g. benzoyl peroxide) inside minute particles built up from absorption enhancer and biological detergent molecules. • This formulation technique potentially delivers effective concentrations of drugs which would normally be insoluble in aqueous based formulations and difficult to deliver and absorbed through the skin. • The micelles also protect the entrapped drug from hydrolysis by enzymes or from pH environments and thus enable more active medication to be delivered to their site of action. SEM-Photograph- 250x SEM-Photograph- 1000x
Advantages of Micellar Technology …
• Micelles are multi layered nano-particles drug delivery technologies• Composed of FDA approved excipients (ingredients)• Technology; formulation, process as well as a delivery technology • Technology is highly adaptable to most high molecular weight drugs, proteins, peptides and insoluble hydrophobic molecules• Capable of delivering more than one therapeutic agent at a time• The platform technology can also be extended to developed other topical pain management therapy e.g., fast acting topical anesthetics, vaccines delivery, wound healing formulations, etc• Offers high market value by featuring maximum functionality at minimum system complexity and cost• The technology is easily scalable to any size without any complex new equipments need Unique Formulation Properties
• Relovox Formulation is an advanced drug delivery system that provides Combination Therapy acne management system • it combines prescription-grade ingredients in a system that works together to heal and prevent acne. • This unique acne fighting system combines finely milled medical actives combined other special formulation. • These ingredients gently exfoliate skin, unplugs the pores, and attacks acne-causing bacteria, and soothe inflammation. • This Novel combination therapy uses several different medicines in one system to heal the pimples, acne, blemishes• It helps reduced the formation of age spots, and hyper pigmentations by improving the skin appearance in 2-4 weeks instead of 8-12 weeks. How it works:
• Helps to normalize sebum secretion and clear clogged follicles, one of the most aggressive causes of breakouts. • The Acne Formulations with unique trans-dermal delivery properties provide for optimal absorption of nutrients and astringents. • It quickly penetrates into the deep layers of the dermis where healing and regeneration occur- allowing for your skin's miraculous return. • Highly recommended for body acne (cystic especially) as well as a spot treatment for the face. • Very effective in absorbing excess oil, opening clogged pores, and reducing the severity of a breakout. Insoluble vs Novel Soluble Relovox Formulation
Topical BP: Acne
Pilot Clinical Study
• Objective To evaluate the efficacy of the
novel InParT topical (BP 3.5%, 1.5% salicylic acid and 3% Hydrogen peroxide) in moderate to severe acne vulgaris • Design open-label treatment phase,
randomized, parallel-group maintenance phase in comparison with VC (placebo treatment).
• Subjects: 26 patients (male/female 14/12)
• Trial Duration: 8 week Twice a day
Human Clinical studies
Objective: To assess acne improvement and tolerability of the
solubilized benzoyl peroxide topical formulation (3.5%) during 8 weeks of treatment in comparison to a control. Participants: A total of 99 patients aged 12 to 39 years with facial
acne were enrolled in the study.
Intervention: The study was randomized, and controlled by using a
non-medicated (vehicle) cream identical to the base of the active cream. The medication samples were distributed in identical boxed pairs of 30 g tubes labeled “morning application” and “evening application”. The dosage of cream per application was approximately 0. 1 ml, described and demonstrated to patients as a pea-sized amount. Topical BP: Acne
Pilot Clinical Study
• Results:
mean reductions from baseline in non inflammatory and inflammatory lesion count, were 66% and 69% with this novel formulation in comparison with placebo where improvement was 3.7% and 5.2%.
 Results:
 Overall disease severity score mean ± SD 3.7±1.7
 Mean percentage (%) change in papules and pustules
 Baseline week 1 week 2 week 4 week 6 week 8  Incident of >50% global improvement from baseline  Incident of >75% global improvement from baseline  % change non-inflammatory lesions counts 64±22.2 % change inflammatory lesions counts 67±27.3 AEs: There were no SAEs observed
the treatment for the first time (5/26), faded after 5-7 days of the treatment. Thank You

Source: http://tdah.co.kr/down/Acne4.pdf