Minocycline Topicals for Rosacea

[Guide]

There has been at least three pharmaceutical companies researching and testing a topical minocycline foam or gel for rosacea. We await to see the results of these clinical trials and if these are effective and which one will be released first. It looks like Foamix, a subsidiary of Menlo Therapeutics, has announced Amzeeq (for acne) and Zilxi (for rosacea) as the front runners if you scroll past this post and go to post number five in this thread. We will continue to follow the other 'horses' in this race. 

(1) FMX103 Topical Minocycline Foam, Foamix Ltd

(2) BPX-04 Minocycline Topical Gel 1%, BioPharmX, Inc.

(3) HY-01 Minocycline Gel 3%, Hovione

 

[Guide]

A paper published in the British Journal of Dermatology concluded that after treatment with 1% and 3% Minocycline Topical Gel, this resulted with a "significantly decreased inflammatory lesion counts and a significantly larger proportion of subjects achieved IGA success at week 12 in the 3% topical minocycline group. These findings support further evaluation of minocycline gel for the treatment of inflammatory lesions associated with papulopustular rosacea."

Metronidazole will be having some competition. 

[Guide]

Results of Two Phase 3, Randomized, Clinical Trials, FMX103 1.5%, conclusion: 

FMX103 1.5% was efficacious for moderate-to-severe papulopustular rosacea, while maintaining a favorable safety profile

The authors of the paper add this limitation, "The generalizability of these data from a controlled clinical trial should be examined in a real-world setting."

For more information

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FMX101 4% for Acne

"In conclusion, the topical formulation of minocycline in FMX101 4% represents a unique treatment for acne vulgaris and a viable alternative to oral administration."

J Clin Aesthet Dermatol. 2020 Apr; 13(4): 14–21.
Formulation and Profile of FMX101 4% Minocycline Topical Foam for the Treatment of Acne Vulgaris
Leon Kircik, MD, James Q Del Rosso, DO, Jonathan S Weiss, MD, Vassilis Stakias, PharmD, Anat London, PhD, Rita Keynan, Yohan Hazot, Russell Elliott, PhD, and Iain Stuart, PhD

[Guide]

"Webster et al. report a multicentre, randomized, double‐masked, parallel‐group, vehicle‐controlled study to evaluate the safety and efficacy of minocycline gel 1% and 3%. Topical minocycline had insignificant systemic absorption but produced significant reductions in mean inflammatory lesion counts with both the 1% and 3% concentrations. The response rate in the vehicle group was quite high, as is often the case in diseases with fluctuating inflammation. However, the 3% concentration of minocycline showed a significantly greater proportion of patients achieving Investigator's Global Assessment success at week 12 compared with vehicle. A topical minocycline foam formulation is in development, and this may provide a further useful option for treating papulopustular rosacea. How topical minocycline compares with other topical rosacea treatments is as yet unclear."

Br J Dermatol. 2020 Mar 18;:
Expanding treatment options for rosacea.
Hampton PJ

[Guide]

Menlo Therapeutics Inc. announced that the U.S. Food and Drug Administration (FDA) has approved ZILXI™ (minocycline) topical foam, 1.5%, for the treatment of inflammatory lesions of rosacea in adults. ZILXI, developed as FMX103 by Menlo’s wholly-owned subsidiary Foamix Pharmaceuticals Ltd. (“Foamix”), is the first minocycline product of any kind to be approved by the FDA for use in rosacea. Official Announcement

Zilzi is a tetracycline that has done well in clinical trials. You will need to ask your physician for a prescription. 

Product Insert

 

[Guide]

Before/after photos released by an investor presentation dated March 2020

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[Guide]

amzeeq (minocycline) topical foam, 4% is for acne which has been FDA approved and is available and Zilxi 1.5% for rosacea available. 

 

[Guide]

"Overall, the current study demonstrates that topical minocycline gel is safe, efficacious and well tolerated in patients with papulopustular rosacea. The findings of this study support further evaluation of topical minocycline gel for the treatment of papulopustular rosacea."

Br J Dermatol. 2020 Sep; 183(3): 471–479. With Photos
A multicentre, randomized, double‐masked, parallel group, vehicle‐controlled phase IIb study to evaluate the safety and efficacy of 1% and 3% topical minocycline gel in patients with papulopustular rosacea
G. Webster, Z.D. Draelos,  E. Graber,  M.S. Lee,  S. Dhawan,  M. Salman,  and G.N. Magrath

[Guide]

Now available announced by Vyne Therapeutics. Ask your dermatologist. Post your experience in this thread. Find the reply button. 

"The Company also announced that the annual list price of ZILXI will be $485 per 30-gram canister, in parity with the wholesale price of AMZEEQ® (minocycline) topical foam, 4%, the Company's topical minocycline indicated for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in adults and pediatric patients 9 years of age and older." 
PR Newswire Association LLC. All Rights Reserved. A Cision company

[Guide]

Long term minocycline use has been associated with hyperpigmentation, i.e., scleral hyperpigmentation, combined with ear and fingernail discoloration. 

Scleral Discoloration Because of Minocycline Use: A Case Report and Review of the Literature

[Guide]

"Here, we review adverse effects and drug-drug interactions observed with oral administration of minocycline and contrast this with topical minocycline formulations recently approved or under development for effectively treating dermatological disorders with fewer adverse effects and less drug interaction."

A Review of Systemic Minocycline Side Effects and Topical Minocycline as a Safer Alternative for Treating Acne and Rosacea

[Guide]

"Minocycline hydrochloride combined with photodynamic therapy can effectively improve the skin barrier function of patients, relieve clinical symptoms, and enhance the overall efficacy and quality of life. It is also safe and patients are highly satisfied with the cosmetic effect."

Effect of minocycline hydrochloride combined with photodynamic therapy on skin barrier function of patients with acne
Am J Transl Res. 2021; 13(7): 8427–8432.