Doxycycline is as good as Low Dose Accutane (0.3mg/kg/day)

Written by on December 15, 2010 in Accutane and Roaccutane, doxycycline with 5 Comments

This study as described in a AAD Poster Session, compared 3 different doses of isotretinoin/accutane with a somewhat standard low dose  regime of doxycyline.

The study was able to show that 0.3mg/kg/day of accutane was as effective as 100mg of Doxycycline for 14 days; followed by 50mg a day thereafter.

A dose of accutane of 0.3mg/kg/day is 18mg per day for a 60kg person (132 pounds).

There are other studies for low dose accutane that used doses more like the the very low 0.1mg/kg/day also examined in this trial.

The standard therapy with oral antibiotics for rosacea is described here as 100mg a day of doxycycline for 14 days and then the sub-antimicrobial dose of 50mg a day thereafter. Oracea is a similar low dose doxycycline, comprising a daily treatment of 30mg plus 10mg delayed release.

My Take

Whilst this study was able to show that around 20mg a day of accutane compared favorably to 100/50mg of doxycyline, because of the higher safety concerns with accutane, I would think doxycycline would win in most clinical situations. If you are getting a benefit from a low dose of doxycycline, seek thorough advice before considering switching to accutane.

J Am Acad Dermatol 2009;60:AB41. Abstract P1162

http://www.aad.org/meetings/annual/_doc/JaadPosterAbstractSupplement.pdf

Double-blind, double-dummy, randomized, placebo-controlled, five armed, multicenter phase II/III study to evaluate the efficacy and safety of different concentrations of isotretinoin versus doxycycline in the treatment of rosacea, subtype II and III

Harald Gollnick, University Magdeburg, Magdeburg, Sachsen-Anhalt, Germany, Carmen Matthies, Almirall Hermal GmbH, Reinbek, Schleswig-Holstein, Germany, Renate von der Weth, Almirall Hermal GmbH, Reinbek, SchleswigHolstein, Germany

A double-blind, randomized, placebo-controlled, five-armed, multicenter study including 573 patients with rosacea subtypes II and III in 35 centers in Germany was performed to evaluate the efficacy and safety of different concentrations of isotretinoin in the treatment of rosacea. Patients were treated in a randomized assignment either with one of three different doses of isotretinoin (0.1, 0.3, or 0.5 mg/kg body weight), with standard therapy with oral antibiotics (100 mg doxycycline daily for 14 days, then reduction to 50 mg daily), or with placebo.

As the primary objective, the reduction in the total sum of facial papules and pustules/noduli after a 12-week treatment was compared between the treatment groups.

In an interim analysis after about 45 patients per group had been treated, all three isotretinoin doses showed a clearly higher reduction of lesions compared to placebo, whereas treatment with 0.3 mg/kg showed the clearest reduction of lesions with a statistically significant superiority versus placebo (P < .005).

In the second part of the study, the efficacy of the most efficient isotretinoin dose (0.3 mg/kg) was compared to standard therapy with doxycycline, and the other arms of the study were closed. Treatment with isotretinoin 0.3 mg/kg showed statistically significant non inferiority versus treatment with doxycycline (P <  .001).

With isotretinoin 0.3 mg/kg, lesions were reduced for 90% compared to 83% with doxycycline treatment. Physicians diagnosed complete remission in 24% and marked improvement in further 57% of the patients with isotretinoin treatment, versus remission in 14% and marked improvement in 55% of the patients treated with doxycycline. Seventy-eight per cent of the patients treated with isotretinoin rated therapy success as ‘‘excellent’’ or ‘‘good,’’ compared to 64% of the patients treated with doxycycline.

Data on drug safety reveal a similar safety profile for the treatment of rosacea with isotretinoin 0.3 mg/kg as with treatment of acne with isotretinoin. No new, severe safety concerns were found; only an increase of cholesterol occurred slightly more often (in 19% of patients) than in acne treatment. Clinically relevant changes in blood count did not occur in any patient. Because of the low dose, isotretinoin has a positive risk/benefit profile for the treatment of rosacea.

Isotretinoin 0.3 mg/kg is an efficient and well tolerated treatment for rosacea subtypes II and III and can be used as an alternative to standard therapy with oral antibiotics.

Commercial support: The study was sponsored by Laboratories Almirall, S.A.

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About the Author: David Pascoe started the Rosacea Support Group in October 1998. .

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5 Reader Comments

  1. grace says:

    the title of this piece is misleading. it sounds like you’re making a case for doxcycline–when in reality the main point is that accutane is just as good, if not better. not vise versa per the title.

  2. Hi Grace,

    The study was to compare 3 different doses of accutane against doxycycline. I would guess at the outset they wanted to see which of the doses would be a closest match to 100/50mg of doxycycline.

    As accutane is much more controversial than doxycycline; harder to get, more possible side effects etc, I thought it was more relevant to reverse the word order and say that doxycycline is similarly as effective as accutane 0.3mg/kg/day.

    I don’t think I’m saying anything that the study doesn’t support.

    cheers,
    davidp.

  3. grace says:

    you don’t quite understand. but i didn’t think you would. the title does not echo the thesis. the opposite. I’m a professional ghostwriter and more attuned to such things than the average person. though it doesn’t matter. this is a website about rosacea therapies, etc., not the finer points of writing. thanks for all your work.

  4. t.d. murray says:

    i have seen other articles that cite studies in which 50 mg doxy is shown to be at anti-biotic levels in the blood for some hours each day during treatment. could you comment on this? also, do you have any information comparing a dosage of 20 mg twice a day, 40 mg (not oracea) once a day, and 50 mg once a day. have looked all over this website and the internet to no avail.

    thanks, t.d. murray

  5. I have seen other articles that cite studies in which 50 mg doxy is shown to be at anti-biotic levels in the blood for some hours each day during treatment. could you comment on this?

    Not sure what sort of comment you are looking for?

    The graph you are referring to was one that I found in some Collagenex publicity and wasn’t published as a part of a study. Whilst the graph is drawn in such a way to suggest that 50mg a day spikes the active in the plasma concentration, I would expect minimal overall differences between the two dosages regimes.

    On the other hand, doses of 100mg a day would be expected to show a noticeably different concentration profile.

    Also, do you have any information comparing a dosage of 20 mg twice a day, 40 mg (not oracea) once a day, and 50 mg once a day. have looked all over this website and the internet to no avail.

    I’m not aware of any data available for these comparisons, sorry. It certainly wouldn’t be in the interest of Galderma to sponsor a study to compare these cheaper similar-to-oracea doses to Oracea itself.

    Before Oracea came along, Periostat – a 20mg dose of doxycycline, was prescribed twice a day as a rosacea treatment therapy, and is still available as an option – even as a generic.

    My personal opinion is that a comparison of the three doses you mention with Oracea would show little difference in overall benefit. They would all work pretty much the same.

    davidp.

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