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Off-label use in dermatology: Hydroxicine for hypertrophic scars

Leal George — Mon, 01 Feb 2010 09:30:15 +0000

The patient after high doses of systemic corticosteroids started to develop a brutal case of acne and folliculitis.

OFF – LABEL USE IN DERMATOLOGY

The Off-Label use of medications in medicine is a progressive techique, that gets more consistent in an ever-growing fashion. An objective translation of the term would be ” Use not referred on the insert that comes with every medication, inside the box” . The FDA defined the medical expression as ” Use for indication, dosage regimen, dosage recomendations, population or other use parameter not mentioned on the approved insert” (circa 1999) . But, at the same time, the FDA recognized that the off-label use by doctors was occasionally accepted and might represent a pattern of a medical practice. And that the prescribers and others could obtain, upon request, information about the off-label use of medicines, to be provided by the pharmaceutical companies. Many pediatric prescriptions were off – label, and in oncology, many of the therapeutic regimens included off-label use, and other entities like CDC (CENTER FOR DISEASES CONTROL) and other subespecialties used this practice. So that the FDA was about to develop some programs with the objective of a normatization of such use.

In our experience, we decide to use the off-label regimen when all other available official ways to deal with a case have failed, and/or when the patient stresses he / she doesn’t want to cope with such approaches. We explain every single detail of the involved aspects, having in mind, as a very basic point, the PRIMUN NON NOCERE concept.

The patient presented below is a good example. He was practicing bodybuilding, and wanted to “speed up” his physical development. He was told to take some substances that would help. Unfortunately, he was given high doses of systemic corticosteroids, and after some weeks he started to develop a brutal case of acne and folliculitis.

He took many systemic antibiotics, after cultures and so on, and at the end the condition subsided, but as a result he developed many lesions compatible with inestetic hypertrophic scars.

There were many lesions to treat, and the classical topical and intralesional corticosteroid was not a very welcome idea. He also didn’t want to go through cryosurgery, due to the amount of lesions. We presented the idea of the systemic and topical hydroxizine with its anti – fibroblastic actions, and after some weeks of treatment he achieved a good result and got very satisfied

after inflamation subsided, but many hypertrophic lesions developed

A few weeks after topical and systemic hydroxizine:

drug: hydroxizine

dosage: 10 mg a day

topically – a 25 mg tablet dissolved in oil-free vehicle

The final results came within a few months, and the patient could affirm this regimen was the key of the success, specially the topical approach

Cordialmente,

George Leal
Dermatologo
Fortaleza, Brazil

CONSULTA I COLLEGHI: Asymptomatic plaques on the inferior aspects of both legs

Leal George — Sat, 16 Jan 2010 21:25:21 +0000

65 yr old male, otherwise healthy except for a mild hypertension treated with Diovan (valsartan) , in two months has developed plaques on the inferior aspects of both legs. Asymptomatic. Refers recent lab workout with normal results

Culture and direct exam negative for fungus.

An experient dermatologist biopsied: ” Skin fragment with corneal layer showing ortokeratosis and epidermis of usual thickness, wth mild foci of spongiosis. Dermis shows mild superficial perivascular lymphocytic inflamatory infiltrate, with endothelial oedema and erythocyte extravasation, although there are no signs of vascular wall aggresion, like vascular fibrinoid necrosis. Additionally, no evidences of leucocytoclasis . Small hemosiderin deposits on the dermis.

Conclusion – superficial perivascular dermatitis with associated capillaritis. No histological signs to support the clinical hypothesis of Hansen’s Disease (unfortunately, still endemic in Brasil >: ) or Numular Eczema.”

Illustrious friends, what are your impressions and suggestions??

yours,
George Leal
Dermatologist
Fortaleza, Brasil

Consulta i colleghi: CBC superficiale multifocale. Come lo tratteresti?

Leal George — Thu, 19 Nov 2009 09:23:21 +0000

Dear colleagues:
This distinct 80 yr old patient, very dinamic, active, presents with this right malar plaque that I follow since 2005, of course not so big at that time.

At the end of that year he came with a plaque smaller than the one of the picture, bellow. Its excision showed : Basal Cell Carcinoma, lateral and deep margins “free of disease”. The lesion grew again, and in february 2009 he came again and I rx 5fluorouracil aplication. He tolerated well, but some points persisted (july 2009), and a new biopsy in two areas showed, this time, SUPERFICIAL AND MULTIFOCAL BCC.

on the left, below feb 2009 right – after 5fu, a few months later

I decided to refer him to oncology. The surgeon-oncologist that saw him preferred that I used imiquimod, for aesthetic reasons. That’s what I have done. But at the end of two weeks using imiquimod 5 x a week, for a 6 week plan, he appeared with intense inflamation:

So, above reflects the situation at week 2/6 week of imiquimod. The patient, socially very active, didn’t like much this situation, and was also very concerned about infections, etc…Therefore we decided to stop a little the imiquimod, applying some eau thermale ,for a few days, and the inflamation subsided…So we approached him in a lighter way, using imiquimod 3 x a week, which he used 2 more weeks
He came with this picture, on november 12, having used so far, therefore, 2 weeks of conventional bcc regimen of 5 x/week for 2 weeks, then 3 x /week the next 2 weeks…Finally he came as follows:

Now, dear colleagues, comes my question:
1. should I go back to the conventional tx for the next 2 wks, in a total of 6 weeks?
2. maintain the 3 x/week regimen for these last two weeks?? or more weeks???
Many thanks and salute to all,

George Leal
Dermatologo
Fortaleza, Brasile

Plaques on the trunk and forehead. What do you think?

Leal George — Fri, 02 Oct 2009 20:38:24 +0000

This 50 yr old brazilian businessman complaints of plaques on the trunk and forehead, that basically produce no symptoms, but occasionally itch.
It seems to get worse when stressed.
He is hypertense, and takes medications for his blood pressure.

The plaques are nummular, infiltrated, appearing on the forehead, mandibular areas, and dorsum on the trunk. Once they are there, they seem to stand for long time, disappearing when treated with topical steroids, etc…

Our first impressions were of Jessner’s Infiltrate, Nummular Eczema, Granulomatous Diseases like tuberculosis, or even syphilis or sarcoidosis.

One of the first biopsies, back in 2006, showed no epidermal alterations. Dermis with moderate linfomononuclear infiltrate surrounding venulo capillary vessels and annexes. No espumous cells or granulomas observed. Negative Wade and BAAR.

Conclusion = Chronic Active Dermatitis, perivascular and perianexial

One colleague rx thalidomide, but there came leg edema so he stopped. another one offered hydroxichoroquine but patient refused to take it.

In December 2008 I rx topical 0,1% tacrolimus , with good response that lasted a few months.

Next, some older pictures:

After a few months better, he returned later with an exacerbation:

A few yrs later, after the recent rx of tacrolimus:

But on this september 2009 new relapse:

A new biopsy of the trunk plaque:

locally and focally thickened epidermis, due to Acanthosis. Dermis show discrete inflamatory mononuclear infiltrate, predominantly histiocytic, with eventual giant cells that are multinucleated, besides the presence of scarse basophillic mucionous material, that gets colloured by alcian blue, amid of collagen fibers. No parakeratosis neither necrobiosis.

Conclusion – the histopathogy favours the clinical diagnosis of Anular Granuloma.

His blood exams have always been pretty normal, but new ones were requested and are pendind (including FAN, VDRL, HEPATITIS B and C serology, etc)

He was rx broad spectrum antihelmintic + strong photoprotection.

Dear colleagues, what is your opinion about this persistent case??

Thanks in advance,

George Leal
Dermatologist
Fortaleza/Brasil