Lactoferrin + Vitamin E + Zinc for Hormonal Acne

  • STATUS
    Recruiting
  • End date
    Sep 17, 2022
  • participants needed
    136
  • sponsor
    United Laboratories
Updated on 17 December 2021
Accepts healthy volunteers

Summary

We previously showed that twice daily intake of a combination of 100 mg lactoferrin, 11 IU vitamin E, and 5 mg zinc significantly reduced both inflammatory and non-inflammatory acne lesions compared to placebo control. In that study, females showed an overall better response compared to males in terms of total lesions. We speculated that the gender effect may be due to mitigation of the pre- menstrual flare-ups women have that lead to recurring acne, making them have a better response. The objectives of this study are: 1.) to characterize the efficacy and safety of 100 mg lactoferrin + 11 IU vitamin E + 5 mg zinc in the adult female population who suffer from hormonal acne, 2.) to determine whether the anti-acne effect is maintained after treatment stops.

Details
Condition Hormonal Acne
Treatment Placebo, Lactezin
Clinical Study IdentifierNCT05151055
SponsorUnited Laboratories
Last Modified on17 December 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Females aged 22-50
At least 3 inflammatory acne lesions, mostly found on (but not limited to) the lower face
Not responsive to conventional treatment
Clinical diagnosis of mild to moderate acne according to Lehmann et. al

Exclusion Criteria

Females who are pregnant (confirmed by a pregnancy test), breast- feeding, or planning a pregnancy
Post-menopausal women
Current or recent (within 3 months) use of any topical or oral anti- acne products
Hormonal contraceptive intake in the preceding six months
A cancer diagnosis within the past 5 years
History of hypersensitivity to any component of the test product
Current imuunosuppression. Specifically, these include patients with co-morbidities such as diabetes, HIV, chronic diseases patients requiring maintenance medications, such as vascular disease
hepatitis, eczema, psoriasis, or acute febrile/infectious illnesses
(i.e. Dengue, pneumonia, etc)
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note