Clinical trial NCT03065504: Turmeric and Turmeric-containing Tablets and Sebum Production
Official title: Pilot Study on the Effects of Oral Turmeric and Turmeric-containing Tablets on Sebum Production
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Inflammation
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2017-02-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: A noticeably increasing number of patients are asking for naturally based extracts and ingredients as supplementary dermatologic remedies. Patients are seeking natural and cost-effective skin care alternatives in place of prescription medications and procedures. This study will isolate the effects of oral turmeric and assess a combination tablet that includes turmeric on sebum production in healthy subjects.

Detailed description: Turmeric (Curcuma longa) is a spice that has been shown to exhibit anti-inflammatory, antimicrobial, antioxidant, anti-neoplastic properties, and even potential to improve mental illnesses. In western herbalism, Turmeric is primarily used as an anti-inflammatory agent. In India, turmeric is used in Ayurvedic medicine for the treatment of acne. It has been used both internally and externally.

Curcumin is a phytochemical derived from turmeric and believed to be one of the key active components of turmeric. Curcumin is reported to have activity as an antibacterial and anti-inflammatory agent and has been used as a paste for skin eruptions and infections. Previous basic science work by Dr. Raja Sivamani's lab has shown that both turmeric and curcumin inhibit lipid synthesis in human sebocytes, the cells responsible for the production of sebum

The goal of this study is to evaluate how ingestion of turmeric and tablets that have a combination of herbs including turmeric may modulate sebum production.

Eligibility criteria: Inclusion Criteria:

1. Age 18 to 50 years of age, and
2. Subject must be able to read and comprehend study procedures and consent forms.

Exclusion Criteria:

1. Subject should be generally healthy and have no smoking history in the past one year, and must have no history of diabetes, metabolic syndrome, known cardiovascular disease, malignancy, kidney disease, or chronic steroid use.
2. Subjects who consume more than 6 servings of caffeine per day, such as coffee and energy drinks (example - Red Bull).
3. Subjects with known allergies to herbal ingredients.
4. Subjects with known EKG changes.
5. Those who used topical medications in the past two weeks or systemic antibiotics within one month of starting the study.
6. Subjects who are postmenopausal
7. Those who are pregnant or breastfeeding.
8. Those that are prisoners or cognitively impaired.

Primary outcomes:
measure: Change in facial Sebum production at 4 weeks
timeFrame: 4 weeks
Secondary outcomes:
measure: Change from baseline in sebum profile, such as inflammatory markers, at 4 weeks
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California, Davis Dermatology Clinical Trials Unit
state: California
Study officials:
affiliation: University of California, Davis
name: Raja K Sivamani, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thangapazham RL, Sharma A, Maheshwari RK. Beneficial role of curcumin in skin diseases. Adv Exp Med Biol. 2007;595:343-57. doi: 10.1007/978-0-387-46401-5_15.
citation: Chainani-Wu N. Safety and anti-inflammatory activity of curcumin: a component of tumeric (Curcuma longa). J Altern Complement Med. 2003 Feb;9(1):161-8. doi: 10.1089/107555303321223035.
citation: Vaughn AR, Pourang A, Clark AK, Burney W, Sivamani RK. Dietary supplementation with turmeric polyherbal formulation decreases facial redness: a randomized double-blind controlled pilot study. J Integr Med. 2019 Jan;17(1):20-23. doi: 10.1016/j.joim.2018.11.004. Epub 2018 Nov 22.