A Report of Three Cases with Moderate Psoriasis Treated with New Topical Treatment

: Practice guidelines recommend fixed combinations of calcipotriol, a topical vitamin D analogue, and betamethasone dipropionate, a high potency corticosteroid, as first line topical treatment for mild to moderate plaque psoriasis of the body and scalp. A new foaming lotion for treatment of Psoriasis was developed and patented by the Spanish Ministry of Industry, Trade and Tourism (Invention patent reference number 202030824). The foaming lotion is composed of clobetasol, papaverine hydrochloride, spironolactone, milk-peptide-complex and propylene glycol. Three cases with moderate Psoriasis aged 34, 36 and 66 years old were treated with our new foaming lotion for 7-8 days. The three patients reported important improvement in the itching sensations and remission of the scaled lesions. Before and after application of the new foaming lotion, Psoriasis Area Severity Index (PASI) scores improved in the first patient from 24.3 to 1.8, in the second patient from 26.1 to 1.8, and in the third patient from 27 to 1.8. Our results show the short-term effectiveness of the new foaming lotion in treating moderate and extensive Psoriasis. Long follow-up is needed to evaluate the remission period of Psoriasis and possible side effects of the new topical treatment.


Introduction
Psoriasis is a chronic papulosquamous skin disease, presenting at any age, and leading to an important deterioration of the quality of life of affected patients.Complications of psoriasis include depression, psoriatic arthritis, and cardiometabolic syndrome [1].
Treatments of Psoriasis include topical agents for mild disease, topical agents and phototherapy for moderate disease, and systemic agents including photochemotherapy, oral agents, and newer injectable biological agents for severe psoriasis [2].
Because of the strong and extensive evidence, the American and European guidelines recommended fixed combinations of calcipotriol, a topical vitamin D analogue, and betamethasone dipropionate, a high potency corticosteroid, as the first line topical treatment for mild to moderate plaque psoriasis of the body and scalp [3,4].
Long-term use of topical corticosteroids, like clobetasol propionate, can result in numerous adverse effects including skin atrophy, formation of striae, telangiectasia, and hypothalamic pituitary adrenal axis suppression [5].
Clobetasol propionate has a vasoconstrictor effect on the peripheral dermal vessels, and this is the reason for skin atrophy in psoriatic patients applying it for long times [6].
A new foaming lotion for psoriasis was developed and patented by the Spanish Ministry of Industry, Trade and Tourism (Invention patent reference number 202030824).The foaming lotion "Psorisbye" is composed of clobetasol, papaverine hydrochloride, spironolactone, milk-peptide-complex and propylene glycol.We describe and summarize three cases of moderate Psoriasis treated with our new patented foaming lotion "Psorisbye".

Psoriasis Case 1
A 34-year-old male presented with extensive Psoriasis lesions in the trunk, and upper and lower limbs.The patient had irrelevant past medical history, and was complaining mainly from itching in the psoriatic lesions.
On examination, it was observed multiple plaque lesions in the chest, abdomen, back, elbows, arms, forearms, popliteal regions and back areas of the legs.Patients was diagnosed 15 years ago and was treated with calcipotriol and betamethasone cutaneous foam (Enstilar® or Daivobet® ).The patient was not previously treated with immunosuppressive drugs like methotrexate or cyclosporine.
The patient was instructed to use our new patented foaming lotion "Psorisbye" once daily for one week.A total of 120ml of "Psorisbye" was used for 1 week.
After 7 days of local application of "Psorisbye" the patient was examined in the outpatient clinic.The patient reported remission of the scaled lesions and important improvement in the itching sensations.
Comparing the psoriatic lesions before and after the application of "Psorisbye" for 7 days, it was observed that Psoriasis Area Severity Index (PASI) score improved from 24.3 to 1.8.
Figure 1 shows the left leg of the patient before and after the application of the new topical treatment with 7 days apart.

Psoriasis Case 2
A 39-year-old male presented with extensive Psoriasis lesions in the scalp, and upper and lower limbs.The patient had irrelevant past medical history, and was complaining mainly from itching in the psoriatic lesions.
On examination, it was observed multiple plaque lesions in the scalp, retroauricular region, chest, abdomen, back, elbows, arms, forearms, thighs, popliteal regions and back areas of the legs.Also, few erythrodermic psoriatic lesions were observed mainly in the abdomen and the back.
Patient was diagnosed 16 years ago and was treated with calcipotriol and betamethasone cutaneous foam (Enstilar® or Daivobet® ).The patient was not previously treated with immunosuppressive drugs like methotrexate or cyclosporine.
The patient was instructed to use our new patented foaming lotion "Psorisbye" once daily for 8 days.A total of 120ml of "Psorisbye" was used for 8 days.
After 8 days of local application of "Psorisbye" the patient was examined in the outpatient clinic.The patient reported remission of the scaled lesions and important improvement in the itching sensations.
Comparing the psoriatic lesions before and after the application of "Psorisbye" for 8 days, it was observed that PASI score improved from 26.1 to 1.8.
Figure 2 shows the right forearm of the patient before and after the application of the new topical treatment with 8 days apart.

Psoriasis Case 3
A 66-year-old female presented with extensive Psoriasis lesions in the scalp, trunk, and upper and lower limbs.The patient had irrelevant past medical history, and was complaining mainly from itching in the psoriatic lesions.
On examination, it was observed multiple plaque lesions in the scalp, retroauricular region, chest, abdomen, back, elbows, forearms, wrists, thighs, popliteal regions and back areas of the legs.Also, few erythrodermic psoriatic lesions were observed mainly in the back.
Patient was diagnosed 15 years ago and treated with calcipotriol and betamethasone cutaneous foam (Enstilar® or Daivobet® ).The patient was not previously treated with immunosuppressive drugs like methotrexate or cyclosporine.
The patient was instructed to use our new patented foaming lotion "Psorisbye" once daily for 8 days.A total of 120ml of "Psorisbye" was used for 8 days.
After 8 days of local application of "Psorisbye" the patient was examined in the outpatient clinic.The patient reported remission of the scaled lesions and important improvement in the itching sensations.
Comparing the psoriatic lesions before and after the application of "Psorisbye" for 8 days, it was observed that PASI score improved from 27 to 1.8.
Figure 3 shows both thighs and popliteal regions of the patient before and after the application of the new topical treatment with 8 days apart.

Discussion and Conclusions
Our study presented three patients with moderate Psoriasis that were treated with "Psorisbye", a new foaming lotion, patented recently by the Spanish Ministry of Industry, Trade and Tourism.
The 3 patients reported important improvement in the itching sensations and remission of the scaled lesions.Before and after application of the new foaming lotion, PASI scores improved in the first patient from 24.3 to 1.8, in the second patient from 26.1 to 1.8, and in the third patient from 27 to 1.8.
Our results show the short-term effectiveness of the new foaming lotion "Psorisbye" in treating moderate and extensive Psoriasis.This could be explained by the combined effects and equilibrated dosages of the drugs incorporated in "Psorisbye".
Papaverine hydrochloride is a known potent arteriolar vasodilator that opens potassium channels of the smooth muscles of the peripheral arteries [7].
Spirolactone regulates sebaceous gland activity and reduces the seborrheic hyperproduction [8], frequently occurs in Psoriasis [1].Milk-peptide-complex reactivates skin cells inducing the production of collagen, hyaluronic acid and fibronectin, improving and softening skin's structure [9].Propylene glycol acts by helping the skin to better absorb hydration by providing softness [10].
Although the results in the three cases with moderate Psoriasis are promising, long follow-up is needed to evaluate the remission period of Psoriasis and possible side effects of the new topical treatment.

Figure 1 .
Figure 1.The left leg of the patient before and after the application of the new topical treatment.

Figure 2 .
Figure 2. The right forearm of the patient before and after the application of the new topical treatment.

Figure 3 .
Figure 3. Thighs and popliteal regions of the patient before and after the application of the new topical treatment.