Open-label, 2-period, fixed sequence study to assess the bioavailability of aluminium, formulated as aluminium chlorohydrate, after topical application of a representative antiperspirant formulation in healthy women using a [26Al] microtracer approach

Completed

• Conditions: General health

• Registration Number: NL-OMON46500
• Lead Sponsor: Cosmetics Europe  The Personal Care Association A.I.S.B.L.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 12

Inclusion Criteria

1. Healthy female subjects, 18 to 45 years of age, inclusive. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, a physical examination (with emphasis on the axilla) including vital signs, 12-lead ECG, haematology, blood chemistry, virology and urinalysis;
2. Body mass index (BMI) between 18 and 30 kg/m2, inclusive;
3. Able to communicate well with the investigator in the Dutch language;
4. Able to participate and willing to give written informed consent and to comply with the study restrictions;
5. Subjects should be used to frequent wet shaving with an appropriate female safety razor (electric shaving is not allowed, frequently is defined as at least three times a week);
6. Subjects should be used to frequent use of Al-containing product (frequently is defined as at least 5 times a week).
7. Sufficient venous access to allow blood sampling as per protocol.

Exclusion Criteria

1. Any clinically significant abnormality as determined by medical history taking and physical examinations (e.g. scars, cuts, wounds, tattoos, and/or dermal abnormalities in the axilla) obtained during the screening visit that in the opinion of the investigator would interfere with the study objectives or compromise subject safety;
2. History of pathological scar formation (keloid, hypertrophic scars)
3. A positive pregnancy test and/or nursing at screening;
4. Use of aluminium-containing medications within 21 days prior to investigational product administrations, or less than 5 half-lives, whichever is longer, and during the course of the study;
5. Known allergy for aluminium;
6. Axillary hyperhydrosis (including subjects treated for this condition (e.g. with botox));
7. Clinically relevant abnormal laboratory results, ECG, vital signs, or physical findings at screening that in the opinion of the investigator would interfere with the study objectives or compromise subject safety;
8. Participation in an investigational drug study within 3 months prior to screening or more than 4 times in the past year; or participation in part A
9. Any psychological conditions which, in the opinion of the investigator, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol;
10. History of alcohol or illicit drug abuse (alcohol abuse defined as alcohol consumption > 28 units/week);
11. Donation of blood within 3 months prior to screening or donation of plasma within 14 days prior to screening;
12. Not having a general practitioner;
13. Not willing to accept information transfer which concerns participation in the study, or information regarding health, like laboratory results, findings at anamnesis or physical examination and eventual adverse events to and from his general practitioner;
14. Not willing to give permission to have the general practitioner to be notified upon participation in this study;
15. Not willing to use effective (double barrier) contraception until at least 3 months after last investigational product administration;
16. Subjects who are part of the site staff of CHDR or TNO employees;
17. Having a tattoo applied within 3 months prior to, or during the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified