Trial Watch: New Treatments Coming Soon

Written by on October 6, 2010 in clinical trials, New Rosacea Treatments with 7 Comments


Despite the global financial economic situation and despite the seemingly crowded skincare market, the research and development of rosacea treatments continues at pace. I wonder if you would be surprised to see the number of rosacea clinical trials listed at that have had activity in the last year?

Even though many products never get past official clinical trials, it is still encouraging to see that companies are still willing to invest in research and development.

1. Apremilast

This product is described as “a novel, orally available small molecule compound that exhibits anti-inflammatory activities through the suppression of multiple pro-inflammatory mediators including, TNF-alpha, interleukins 6, 17 & 23, and interferon-gamma among others.””

It will be trialled for both Erythematotelangiectatic Rosacea and Papulopustular Rosacea (see Apremilast from Celgene being trialled for rosacea.)

2. Atralin

Atralin Gel contains Tretinoin 0.05%. Tretinoin is a topical medication that is known to improve photodamage. The study is attempting to find out if Atralin (tretinoin 0.05%) Gel used for up to 46 weeks will improve erythematotelangiectatic rosacea (ETR) (see Atralin Gel (Tretinoin 0.05%) being trialled for the redness of rosacea).

3. Calcium Dobelisate + Pulsed Dye Laser

This study is to determine the efficacy of calcium dobesilate in combination with pulsed dye laser for the treatment of rosacea. Calcium dobesilate (2,5-dihydroxybenzene sulfonate) is a drug that inhibits vascular smooth muscle cell growth and inhibits cellular proliferation (see Doxium being trialled as Pulsed Dye Laser adjunct).

4. CD07805/47 (Sansrosa)

Known previously as Sansrosa, three strengths of CD07805/47 topical gel (0.07%, 0.18%, and 0.50%) are being tested for the redness of rosacea. The study completed in December 2009 so we await the next stage of this product’s development (see Galderma sends Sansrosa backwards – Phase 2 Dosage Trials Again).

5. Finacea + Oracea vs. Metrogel + Oracea

Intendis, the makers of Finacea are sponsoring this trial. Subjects with moderate papulopustular rosacea will be treated either with azelaic acid 15% gel topically plus Oracea or with metronidazole 1% gel topically once daily plus Oracea at total of twelve weeks to determine the rapidity of improvement, and the length of time to reach 25%, 50% and 75% clearing compared to baseline (see ho hum: finacea + oracea vs. metrogel 1% + oracea).

6. Finacea Foam

A new formulation of Finacea, a foam used twice a day is being trialled. Note that they are only comparing the active against the vehicle foam, so will not be able to compare regular topical Finacea with Finacea Foam to see if the foam formulation makes any difference to the outcome (see Finacea Foam being trialled).

7. IDP-115

Dow Pharmaceutical Sciences, which is now owned by Valeant Pharmaceuticals, has completed their trials of something they call IDP-115. Whilst details are sketchy the product appears to be similar to Rosasol, a formulation of metronidazole and sunscreen agents (see Mysterious topical IDP-115 being trialled)

8. Isotretinoin (0.25 mg/kg)

This trial is looking at the medium dosage (15mg a day for a 65kg patient) of Isotretinoin in treating the papules and pustules of rosacea. (See trial NCT00882531). The company sponsoring this trial, Laboratoires Bailleul-Biorga, manufacture Oral Isotretinoin (Accutane) in strengths of 5mg, 10mg, 20mg and 40mg.

9. Minocycline Foam

A special formulation of Topical Minocycline Foam FXFM244 is being trialled in strengths of 1% and 4%. The makers of the foam, Foamix  promote the ease of application and the absence of alcohol in their products, suggesting that it is ideal for many dermatological agents (see Foamix to trial foaming topical minocycline)

10. Nycomed 0444 Gel

This Phase III trial which has listed as completed looked at Nycomed’s 0444 Gel for the treatment of the papules and pustules of rosacea. Not a lot of information has surfaced as yet as to the makeup of this product (see What is this mysterious Nycomed 0444 Gel ?).

11. Oxymetazoline (V-101)

The product is known as V-101 and all indications are that it is a formulation containing oxymetazoline (as found in products like Afrin, Vicks Sinex and Visine). V-101 is being trialled in strengths of 0.01%, 0.06%, 0.1% and 0.15% (see V-101 (Oxymetazoline) starting Dose-Finding Trials).

12. Sol-Gel SGT DER 45 EV Gel

This product know only as DER 45 EV Gel (in strengths of 1% and 5%) has been listed in a dose-range trial for the papules and pustules of rosacea. One guess is that this product is a novel form of benzoyl peroxide, but so far no more information has been published (see Sol-Gel Trialling Benzoyl Peroxide (DER 45 EV) for Rosacea).

13. SR-01

This mysterious topical, being sponsored by Dr. Mark Dahl MD from the Mayo Clinic has listed as completed. SR-01 is listed as a topical agent for the treatment of red skin (see NCT00279890).

14. Topical Oxygen (TDO)

Aria Aesthetics is sponsoring a trial where topically disolved oxygen (TDO) based cosmeceuticals are used to treat several skin conditions (see Topical Oxygen being trialled for sun damaged skin).

15. Ziana

Ziana has been approved as an acne treatment. The aim is to determine whether Clindamycin Phosphate 1.2% And Tretinoin 0.025% Gel are effective and safe in the treatment of papulopustular rosacea. (see Medicis readies to trial Ziana for rosacea)

What do you think?

Are you encouraged by the number of products in this list? Or do they feel all too much like same old same old to you?

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

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7 Reader Comments

  1. Lonna Burfield says:

    They all sound close to the same old but when you rosacea you are willing to try anything that may help.

  2. Marilyn says:

    Hi My name is Marilyn. Would anyone like to be on my website? It is a site about acne and a an ebook product I am promoting that is an holistic approach to acne. I myself am healing my acne rosacea. I have my picture on my site.Need pictures of different types of facial acne or back acne so that I would have original pictures. Please contact me at Thanks so much for your help and I understand the challenges of acne.

  3. Pavla says:

    I am very interested in possible drugs like Apremilast or SIG 990, but not in modifications of Metronidazol creams. Something very new/different is necessary.

  4. Jasmine 215 says:


    I have asked this question over and over again:

    Why do Rosacea medications (or for that matter, ANY type of skin medication) have to be a topical one? They devised Accutane for Acne and other dermatitis conditions, that is an oral pill. So why not something for Rosacea and in my case, seborrheic dermatitis to make it all worse? I saw the Apremilast study and I HOPE this passes all the phases of clinical trials.

    I had just enrolled in a Phase II clinical trial for the new Sansrosa topical, Brimonidine tartrate, but they told me it is now closed to new patients. The man I spoke with at my derm’s office said it works like GANGBUSTERS! Very encouraging.

    It would be more encouraging though, if they could make this in a Pill form. I like pills better than over and over again, using topicals. Had to do too much of this as a young teen-ager with oily skin and acne, on my forehead and nose only. I had to wash my face, no joke every 2 hours every day! It got old quickly.

    Derms have told me that IF I could tolerate oral tetracyclines, I would have NO PROBLEMS! I told them that since I am allergic to ALL of them, I only have topicals to turn to. Even Erythromycin and other antibiotics do NOT work for Rosacea, according to my derm.

  5. Eric says:

    Any updates on this trial NCT00882531?

  6. Hi Eric, I haven’t seen any updates from Laboratoires Bailleul-Biorga. It would be nice if we were able to obtain some feedback from their trials.

  7. I have heard from Bailleul-Biorga and they tell me that they will be publishing the results of the trial of Contracne (Oral Isotretinoin @ 15mg a day for 65kg person) for rosacea, by the end of the year.


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