Clinical trial: Influence of H1-antihistamines on the Dermal Blood Flow Response to Histamine, Cinnamaldehyde and Capsaicin. (NCT04399525)

Eligibility criteria:
Inclusion Criteria:

          -  Subject is a white male ≥ 18 and ≤ 45 years of age at the time of screening

          -  Subject is a nonsmoker for at least 6 months prior to the study start

          -  Subject has a body mass index ≥ 18 and ≤ 30 kg/m2

          -  Subject has a clear increase in histamine-induced dermal blood flow; Subject has an
             increase in capsaicin- and cinnamaldehyde-induced dermal blood flow of at least 100%
             as determined during the screening visit

          -  Subject is judged to be in good health on the basis of medical history, physical
             examination and vital signs

          -  Subject understands the procedures and agrees to comply with them for the entire
             length of the study by giving written informed consent.

        Exclusion Criteria:

          -  Subject has excessive hair growth on the volar surface of the forearm

          -  Subject has a past or present history of diffuse dermatological conditions including
             eczema, scleroderma, psoriasis, urticaria, dermatographism and dermatitis

          -  Subject has any abnormality on the skin of the forearm, possibly interfering with the
             study assessments including tattoos, keloids, tumors, ulcers, burns, flaps and grafts;

          -  Subject cannot avoid excessive tanning (any exposure to sunlight or a tanning bed
             which would cause a sunburn reaction) throughout the study and cannot cover the
             forearms 24 hours before and after each study visit

          -  Subject currently uses lotions, oils, depilatory preparations, makeup or other topical
             treatments on the arms and on a regular basis which cannot be discontinued for the
             duration of the study; subject has used any topical treatments within 7 days of the
             start of the study

          -  Subject has a past or present history of (symptomatic) asthma

          -  Subject has a history of severe allergic reactions to food or drugs or adverse
             experiences of a serious nature related to the administration of either a marketed or
             investigational drug, including histamine, cinnamaldehyde, capsaicin, desloratadine or
             levocetirizine

          -  Subject currently uses any prescription or nonprescription drugs on a regular basis
             which cannot be discontinued for the duration of the study; subject has used any
             prescription or nonprescription medication within 14 days of the start of the study

          -  Subject is a habitual and heavy consumer of coffee or caffeinated beverages (more than
             approximately 4 cups of tea, coffee or cola per day) at the time of the study.
             Subjects who have reduced their consumption to ≤ 4 cups per day at least 1 week prior
             to enrollment may participate; Subjects who cannot refrain from caffeinated beverages
             24 hours before the study visit

          -  Subject is unable to refrain from drinking alcohol 24 hours prior to histamine
             application, is currently a regular user (including "recreational use") of any illicit
             drugs, or has a history of drug (including alcohol) abuse. A drug screen will include
             amphetamines/ methamphetamines, methylenedioxymethamphetamine, benzodiazepines,
             barbiturates, cocaine, cannabis, tricyclic antidepressants, methadone and opiates

          -  Subject cannot refrain from being around second hand smoke 24 hours prior to histamine
             application or uses nicotine-containing products. Ex-smokers should have ceased
             smoking at least 6 months prior to screening

          -  Subject has any of the following vital sign measurements at screening: heart rate ≤ 40
             or ≥ 100 beats/min, diastolic blood pressure ≤ 50 or ≥ 89 mmHg and/or systolic Blood
             Pressure ≤ 90 or ≥ 139 mmHg

          -  Subject has been involved in testing an investigational drug in another clinical study
             within the last 4 weeks or 5 half-lives

          -  Subject has evidence of a clinically significant active infection, fever of 38°C or
             above at the time of the study visits

          -  Subject has a history or current cardiovascular, respiratory, hepatic, renal,
             gastrointestinal or neurological disorders capable of significantly altering the
             absorption, metabolism or elimination of drugs

          -  Subject is in a situation or has a condition, which, in the opinion of the
             investigator, may interfere with safe and optimal participation in the study

          -  Subject has a history of any illness or disorder, which, in the opinion of the
             investigator, might confound the results of the study.
Male
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 45 Years

Patient description (medical language): A 19-year-old girl comes to the clinic due to a left wrist mass.  She noticed swelling on the top of her wrist about 4 months ago and came to the clinic due to cosmetic concerns.  Examination shows a nontender, rounded mass on the dorsal wrist that transilluminates with a penlight. Vital signs are normal. The patient needs to type on her computer almost all day. She is left-handed. She does not smoke or use illicit drugs. She is in sexual relationship with two male partners and uses condoms.

Patient description (patient's own words): I'm a 19-year-old girl and I went to see my doctor because of a mass on my left wrist. I noticed a swelling on top of my wrist, like 4 months ago, and I went the first time to the doctor because it was pretty ugly! My wrist was not tender, and the mass was round and let the light go through when the doctor used a penlight. My blood pressure, breathing and temperature were normal. I'm left-handed and I need to be on my PC all day. I don't smoke or do drugs. I'm sexually active and I have 2 male partners but they all use condoms.

Does the patient match the trial criteria? Contradiction