A panel of dermatology experts reviews the safety and efficacy data of the newly approved topical therapies trifarotene 0.005% cream, tazarotene 0.045% lotion, and minocycline 4% foam.
Hilary E. Baldwin, MD: Julie, can you tell us a bit about trifarotene cream?
Julie C. Harper, MD: Trifarotene cream is a new retinoid molecule, so it’s not a reformulation of something that we’ve had: it’s a whole new molecule. It’s also the first new retinoid molecule for acne in over 20 years. It’s nice that we have this newcomer to use in the armamentarium to treat our patients with acne. There are a couple of things to know about trifarotene. The first is that it is selective for the RAR gamma receptor. I’ll be honest, I’m not certain how important that is. But the RAR gamma, which is the retinoic acid receptor. That is found predominantly in the skin, so it stands to reason that you would want to target the 1 in the skin if we’re trying to treat a skin condition. It is gamma selective.
The other thing that is interesting, though, is if you look at the concentration of trifarotene. I’m going to say a bunch of 0s, and I’m not messing up, OK? It’s 0.005%, and I don’t know of another topical off the top of my head that has such a low percentage. What that means to us is that it is potent at this low concentration, and what that also can means is that it has low systemic exposure when it’s applied to a wider surface area.
I’ve got to say this: They studied it in exactly the same way they studied facial acne. They studied it in truncal acne, so they didn’t do just part of the assessment. If you had moderate acne on the face to begin with, you also had moderate acne on the trunk. We were then going to look at success rates on both the face and the trunk separately and look at lesion count reduction. It was not just the IGA [Investigator’s Global Assessment] success rate, but it was also lesion count reductions on the trunk and face.
In the end, this was something that jumped out to me. I don’t know if this is as important to everyone else, but when we’re treating truncal acne, we sometimes step back a bit, and I don’t know if that’s just our bias. We all assume, “It’s going to be hard for them to rub something on their back, and the back may not doesn’t respond as well as the face anyway.” You know what? At least in this study, it was a defined area, and when you look at the results in this study, the acne on the trunk did just as well. It responded as well as the acne on the face, and it responded as quickly as acne on the face. It makes me look at this and say, “Maybe I don’t have to alter my treatment plan totally as I move from facial acne to truncal acne.” There are products that are going to do double duty, and we have data to show that. I’m glad we’ve talked about truncal acne a lot, and I’m glad we’re getting some data there. Yes, trifarotene cream has probably studied truncal acne—I’m going to go ahead and say it—better than any of the others because it used all the same parameters that it was using on facial acne.
Hilary E. Baldwin, MD: Yes. We have an additional topical retinoid. We’re very retinoid rich lately. It’s tazarotene 0.045% lotion. Fran, have you used it? What’s different about the epidermal delivery system?
Fran E. Cook-Bolden, MD: I have used tazarotene 0.045% lotion. Tazarotene has been around for a long time, and it’s been known. It’s had the reputation as the strong retinoid when treating acne largely because of challenges with tolerability. This epidermal delivery system of tazarotene 0.045% lotion allows it to be what I call the gentle giant: It was created using this novel polymetric emulsion technology that I mentioned before. The benefits of this new technology are that the lotion is highly spreadable. Although there weren’t specific studies done on the trunk, you can use it on the face, but you can certainly use it on the trunk, the chest, and the back. It’s spreadable, and it allows for more efficient delivery of tazarotene deep into the skin while reducing that potential for skin irritation. Tazarotene has had the stigma of being that intolerable retinoid that you can’t use on sensitive skin.
Hilary E. Baldwin, MD: The overall story with these new topicals is that we have greatly improved tolerability across the board, probably because of some of our technologies that go into the manufacturing of these great vehicles. That includes moisturizing agents, and it includes more spreadability and micronization of the particles, which is something we see in the next and last product that we’re going to discuss today: topical minocycline 4% foam. Jim, what has your experience been with this medication?
James Q. Del Rosso, DO: They overcame the challenge of trying to formulate a topical tetracycline in general. We’ve had topical tetracyclines, meclocyclines, and tetracycline, and they all flopped for a variety of reasons when trying to create a topical formulation. With minocycline, the challenge is to get it to be solubilized. You have to use a lot of lipid. Yes, if they put it in lard, the lard could deliver the minocycline. That would be OK, but nobody would want to use lard on their skin. They have to formulate it in something that patients would actually use that would solubilize the minocycline to deliver the minocycline, and they did that with the vehicle formulation that they came up with. They found some oils that are barrier-friendly that also help solubilize them in the cycline. They were able to do that.
The other part of that that’s important is the concentration of the 4% minocycline foam, which is the 1 that’s FDA approved once a day for the treatment of acne. The concentrations are very high in the epidermis and the dermis, so you’re not getting the systemic exposure that could lead to antibiotic resistance in other parts of the body, and you’re not getting systemic exposure that could lead to systemic adverse effects that you might get with oral minocycline.
What was interesting is that a lot of people ask about minocycline hyperpigmentation because you’re getting high concentrations in the skin. I was 1 of the investigators on this particular formulation, and we did see postinflammatory hyperpigmentation focally that we would see related to acne. It is the same with the 1.5% that has been evaluated for rosacea, and it has been recently approved for rosacea. What we did not see in these studies was this: None of the patients was getting the minocycline-associated pigmentation, that diffuse slate-gray color, brownish pigmentation, or even focal-blue hyperpigmentation that we see in scars has not happened in the clinical trial. This all adds up to be an advantage in addition to the levels that get so high in the skin that they appear to get to the mutant-prevention concentration, which means they’re beyond a range where you can select some resistant organisms. The levels are so high that when bacteria try to replicate, the levels are much higher than any of those bacteria could withstand. There are data to suggest that that is the case. We don’t have all the data we need on that.