Sansrosa Phase II Results at 2012 AAD San Diego

Written by on March 29, 2012 in Galderma, Sansrosa with 0 Comments

Some Phase II Trial results for Sansrosa were presented at the recent 2012 AAD Annual Meeting in San Diego.

Joseph F. Fowler, M.D., Clinical Professor of Dermatology at the University of Louisville was the principal study investigator. A summary of these results was mentioned in October 2011 via a press release covered here: Sansrosa not Susceptible to Tolerance or Rebound

Whilst we aren’t told what the adverse events were that affected around 15% of participants, we are told that they were `mild and transient’. One of the aims of the just-completed Phase III trials was to verify that any Adverse Events were not more common in a larger population.

These poster sessions offer further confirmation of the suitability of Galderma’s in-development CD07805/47 Brimonidine Bartrate based gel for the red face of rosacea.

Poster reference number 4825

Once-daily topical brimonidine tartrate gel 0.5% is safe and efficacious in the treatment of moderate to severe persistent facial erythema associated with rosacea

American Academy of Dermatology 70th Annual Meeting, March 16–20, 2012, San Diego, California. Poster Abstracts, Supplement to JAAD, April 2012, Volume 66, Number 4.

Joseph Fowler Jr, MD, University of Louisville, Louisville, KY, United States; Angela Moore, MD, Arlington Center for Dermatology, Arlington, TX, United States; Kappa Meadows, MD, The Education & Research Foundation, Inc, Lynchburg, VA, United States; Kimberly Grande, MD, The Skin Wellness Center, Knoxville, TN, United States

Brimonidine tartrate (BT), a highly selective a2-adrenergic receptor agonist with vasoconstrictive activity, was previously shown to significantly reduce persistent facial erythema associated with rosacea when applied as a topical gel.

The safety and efficacy of BT gel in this indication was assessed in this multicenter, double-blind, randomized, vehicle controlled phase II study (4 weeks daily treatment/4 weeks follow-up).

Erythema severity was assessed using two 5-point scales (0 = clear to 4 = severe), Clinician’s Erythema Assessment (CEA), and Patient’s Self-Assessment (PSA).

Subjects (n = 269) with moderate to severe facial erythema of rosacea (CEA and PSA scores $3) were randomized to one of five groups: BT 0.5% once daily (QD), BT 0.18% QD or twice daily (BID), or vehicle QD or BID.

BT 0.5% QD had a significantly superior success profile (defined as a 2-grade improvement profile on both CEA and PSA over 12 hours) compared to vehicle QD on day 29 (primary endpoint, P<.001), and on days 1 and 15 (both P<.001).

Success rates at hours 3, 6, 9, and 12 on day 29 were 30.2%, 28.3%, 32.1%, and 18.9%, respectively, for BT 0.5% QD, compared to 3.6%, 7.3%, 3.6%, and 3.6% for vehicle QD.

Results from the primary analyses were confirmed by the secondary analyses. BT 0.18% BID and QD were more efficacious than the vehicle BID and QD, respectively, although the differences were not always statistically significant.

No evidence of tachyphylaxis, rebound, or aggravation of other disease signs (telangiectasias, inflammatory lesions) was observed for any active treatment group.

Similar incidences of related adverse events (AEs) were reported for the active groups (11.1-18.9%) and the vehicle QD group (14.5%). Most related AEs were mild and transient.

In conclusion, BT gel 0.5% is safe and efficacious for the daily treatment of moderate to severe facial erythema associated with rosacea.

Fowler, Moore, Meadows and Grande all list financial relationships with Galderma in the Author Disclosures Appendix.


Poster reference number 4764

A single application of brimonidine tartrate gel significantly reduces moderate to severe facial erythema associated with rosacea

Kappa Meadows, MD, The Education & Research Foundation, Inc, Lynchburg, VA, United States; Andrew Pollack, MD, Philadelphia Institute of Dermatology, Fort Washington, PA, United States; Michael Jarratt, MD, DermResearch, Inc, Austin, TX, United States; Terry Jones, MD, J & S Studies, Bryan, TX, United States

Brimonidine tartrate (BT), a highly selective a2-adrenergic receptor agonist, was originally approved for the treatment of glaucoma. Due to its vasoconstrictive activity, BT was hypothesized to have the ability to reduce persistent cutaneous facial erythema associated with rosacea.

Since there are currently no pharmaceutical agents approved for this treatment indication, the effect of topical BT gel on the facial erythema of rosacea was evaluated in this double-blind, randomized, vehicle controlled, dose-finding study.

Erythema severity was assessed using two 5-point scales, Clinician’s Erythema Assessment (CEA) and Patient’s Self-Assessment (PSA).

Subjects (n = 122) with moderate to severe facial erythema from rosacea (CEA and PSA scores >3) were randomized to receive a single facial application of BT gel 0.07%, 0.18%, 0.5%, or vehicle.

A single application of topical BT gel was shown to significantly reduce facial erythema. The effect was superior to vehicle and consistently dose-dependent, with the highest concentration (0.5%) having the greatest strength and duration of effect.

The response rate for a 2-grade improvement on both CEA and PSA was 25.0%, 32.3%, and 54.8% for BT gel 0.07%, 0.18%, and 0.5%, respectively, compared to 12.5% for vehicle.

The median duration of effect after a single application of BT gel 0.5% was 11.53 hours (1-grade of improvement on CEA), 7.00 hours (2-grade of improvement on CEA), and 5.98 hours (2-grade of improvement on both CEA and PSA).

All tested BT gel concentrations were safe and well-tolerated. The incidence of subjects with related adverse events (AEs) ranged from 6.5% (2 subjects) with BT gel 0.5% to 14.3% (4 subjects) with BT gel 0.07%.

Most related AEs were transient, dermatological in nature, and mild in intensity.

In summary, topical BT gel significantly reduces facial erythema associated with rosacea in a dose-dependent fashion, with BT gel 0.5% providing superior strength and duration of effect.

Commercial support: Galderma Laboratories, L.P.

Meadows, Pollack, Jarratt and Jones all list financial relationships with Galderma in the Author Disclosures Appendix.

Related Articles

Read more about: Galderma, Sansrosa

About the Author

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

Follow Rosacea Support

Subscribe via RSS Feed Connect on Pinterest Connect on Google Plus

Leave your comment here

Top

Subscribe to Rosacea News

Enter your email address to receive the latest news about rosacea in your inbox.