Randomized placebo-controlled trial of a flavonoid-rich plant extract-based cream in the treatment of rosacea.
BACKGROUND
Biological research suggests that vascular changes may play a major role in rosacea pathogenesis. Chrysanthellum indicum is a plant-based extract containing a unique combination of phenylpropenoic acids, flavonoids and saponosids, and has a well-documented effect on vascular wall permeability and increase of the mechanical resistance of capillaries.


OBJECTIVE
To determine the efficacy and safety of a cream containing 1%C. indicum extract with vitamin P properties in the treatment of rosacea.


METHODS
This study included 246 patients diagnosed clinically as having moderate rosacea. Patients were randomly allocated to C. indicum extract-based cream (n = 125) and placebo (n = 121) groups. Patients were advised to apply the products on their face twice a day for a 12-week period. The patients were examined at the end of each 4-week period. Severity of erythema (graded by reference to six photographs), surface of erythema and rosacea overall severity scores were recorded at each visit on days 0, 28, 56 and 84. Investigators carried out a final efficacy assessment at the end of week 12. Volunteers' final overall efficacy assessment was recorded in a self-administered questionnaire. Adverse events were identified through examination, interview and collection of comments in patients' questionnaires.


RESULTS
Treatment with the C. indicum extract-based cream resulted in significant improvement (P < 0.05) in severity of erythema, overall rosacea severity compared to baseline and placebo, and investigator and patient overall efficacy assessment scores (P = 0.046 and P = 0.001, respectively) compared with placebo scores. Adverse reactions were mild, and did not differ between the C. indicum extract-based cream and the placebo groups.


CONCLUSIONS
Chrysanthellum indicum extract-based cream is an effective and well-tolerated topical agent for the treatment of moderate rosacea. The mode of action of the active ingredient suggests that additional efficacy might be expected from combination with other topical treatments.
Rigopoulos
D
D
Department of Dermatology, University of Athens, Andreas Sygros Hospital, Athens, Greece. stamgreg@yahoo.gr
Kalogeromitros
D
D
Gregoriou
S
S
Pacouret
J M
JM
Koch
C
C
Fisher
N
N
Bachmann
K
K
Brown
M
M
Schwarz
E
E
Camel
E
E
Katsambas
A
A
D000287:Administration, Topical; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004643:Emollients; D005260:Female; D005419:Flavonoids / Q000627:therapeutic use*; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D010936:Plant Extracts / Q000627:therapeutic use*; D011336:Probability; D012016:Reference Values; D012393:Rosacea / Q000175:diagnosis* / Q000188:drug therapy*; D012720:Severity of Illness Index; D016896:Treatment Outcome
D004643:Emollients; D005419:Flavonoids; D010936:Plant Extracts