METHOD FOR MEASURING FLUSHING AND USE FOR ASSESSING TREATMENTS

• US 20160051181A1
• Filed: 03/28/2014
• Published: 02/25/2016
• Est. Priority Date: 03/29/2013
• Status: Active Grant

• Current Assignee: Galderma Research And Development Snc (Nestle SA)
• Original Assignee: Galderma Research And Development Snc (Nestle SA)
• Inventors: PETIT, Laurent, DUGARET, Anne-Sophie
• Granted Patent: US 10,448,880 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 5/0261 using optical means, e.g. infrared light
• CPC Class Codes: A61B 5/1032 Determining colour for diagnostic purposes measuring colour in general G01J3/46
• CPC Class Codes: A61B 5/445 Evaluating skin irritation or skin trauma, e.g. rash, eczema, wound, bed sore
• CPC Class Codes: A61B 5/4848 Monitoring or testing the effects of treatment, e.g. of medication
• CPC Class Codes: A61B 5/6814 Head
• CPC Class Codes: A61B 5/7225 Details of analog processing, e.g. isolation amplifier, gain or sensitivity adjustment, filtering, baseline or drift compensation A61B5/30, A61B5/316 take precedence; transformers for specific applications H01F38/00; amplifiers H03F

Abstract

A method is described that makes it possible to measure flushing, particularly in the context of the study of rosacea, and to distinguish normal flushing from pathological flushing. Also described, is the use of said method to study the effect of drug candidates, particularly against rosacea. The method can include: a) subjecting the subject to a flushing inducing stimulus; b) measuring the inflow of blood in the face of the subject during a time period covering the flushing; and c) calculating entropy of the inflow of blood.

Claims

1. A method for measuring a flush in a subject, the method comprising:

a) subjecting the subject to a stimulus inducing a flush;

b) measuring blood inflow at the subject'"'"'s face for a period of time covering the flushing; and

,

c) calculating entropy of the blood inflow.

2. The method according to claim 1, wherein the measurement of the blood inflow at the subject'"'"'s face is made by measuring intensity of the blood flow in surface skin portions of the face and/or measuring a color of skin on the face.

3. The method according to claim 2, wherein the measurement of the blood flow intensity in the surface skin portions of subject'"'"'s the face is made by measuring blood microcirculation.

4. The method according to claim 3, wherein the measurement of the blood flow intensity in the surface skin portions of the subject'"'"'s face is made by an analysis of laser granularity contrast.

5. The method according to claim 1, wherein the measurement of the blood inflow is made on one or both cheeks of the subject'"'"'s face.

6. The method according to claim 1, wherein the period of time during which the blood inflow is measured, is from 30 min to 1 hour and 30 minutes.

7. The method according to claim 1, wherein the method further comprises regular evaluation of a heat sensation felt by the subject.

8. The method according to claim 1, wherein the stimulus inducing the flush is hot drink, absorption of a spice, or an alcoholic beverage.

9. The method according to claim 1, wherein the calculated entropy is indicative either of normal flush, or pathological flush.

10. The method according to claim 1, wherein the calculated entropy is compared with a range of reference entropy values.

11. The method according to claim 1, wherein the entropy is calculated with the following formula:

Entropy=−

Σ

(N(i)/Nt*log (N(i)/Nt))

wherein N(i) is the number of points per intensity interval of the blood flow; and

Nt is the total number of points, i.e. Nt=Σ

N(i).

12. The method according claim 1, wherein several measurements of flushes are carried out for one subject.

13. The method according to claim 12, wherein measurements are carried out on the left and right cheeks of the subject'"'"'s face and the entropy is calculated either for each cheek or by averaging the measurement of both cheeks.

14. The method according to claim 12, wherein the measurement is carried out on a subject before and after treatment with a drug or drug candidate, a cosmetic product or a medical device.

15. The method according to claim 12, wherein the measurement is carried out on a subject on one cheek which has not received any treatment or has received a reference treatment or a placebo, and on the other cheek that has received a treatment with a drug or drug candidate, a cosmetic product or a medical device.

16. The method according to claim 14, wherein the entropies calculated without any treatment or with treatment with a reference treatment or a placebo and with a treatment by a drug or drug candidate, a cosmetic product or a medical device, are compared and allow determination of the therapeutic efficiency of said drug or drug candidate, cosmetic product or medical device.

17. The method according to claim 14, wherein the drug or drug candidate is intended for treating rosacea.

18. A method of determining the efficacy of a drug or drug candidate, of a cosmetic product or of a medical device, the method comprising conducting the method of claim 1 to determine if the drug, drug candidate, cosmetic product or medical device is effective in reducing or suppressing pathological flushes.

19. The method according to claim 18, wherein the pathological flushes are associated with rosacea.

20. The method according to claim 19, wherein the pathological flushes are associated with erythemotelangiectasic rosacea of subtype I.

21. The method according to claim 19, wherein the pathological flushes are associated with papulopustular rosacea of subtype II.

22. The method according to claim 2, wherein the color of the skin on the subject'"'"'s face that is measured is redness.

23. The method according to claim 3, wherein the blood microcirculation is measured using a system based on the Doppler effect or with a system based on an analysis of laser granularity contrast.

24. The method according to claim 4,wherein the laser granularity contrast analysis is made by means of an FLPI (full field laser perfusion imaging) imager.

25. The method according to claim 6, wherein the period of time during which the blood inflow is measured, is from 45 minutes to 60 minutes.

26. The method according to claim 8, wherein the stimulus is a hot drink or absorption of a spice.

27. The method according to claim 26, wherein the stimulus is a hot drink.

28. The method according to claim 10, wherein the calculated entropy values are compared with a range of characteristic entropy values of a normal flush and/or with a range of entropy values characteristic of a pathological flush.