NCT03066791

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. Our study will evaluate the effects of oral curcumin and turmeric on sebum production in healthy subjects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 1, 2016

Completed
29 days until next milestone

Study Start

First participant enrolled

November 30, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 28, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 28, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2017

Completed
Last Updated

December 19, 2018

Status Verified

December 1, 2018

Enrollment Period

9 months

First QC Date

November 1, 2016

Last Update Submit

December 18, 2018

Conditions

Inflammation; Skin

Outcome Measures

Primary Outcomes (1)

  • Sebum production

    Sebutapes will be used to measure sebum production at each visit. The sebutapes will then be collected and analyzed for fatty acids and lipid production.

    8 weeks

Secondary Outcomes (2)

  • Change from Baseline in Sebum profile, such as inflammatory markers at 8 weeks

    8 weeks

  • Change in stool microbiome diversity (optional collections for subjects) from baseline at 8 weeks

    8 weeks

Study Arms (3)

Turmeric group

ACTIVE COMPARATOR

Turmeric Tablets: Each tablet contains 1,000 mg of Turmeric (Curcuma Longa) per tablet. Dose: subjects will take 6 tablets per day, with a total daily dose of 6,000 mg. Supplied by Sabinsa Corporation

Dietary Supplement: Turmeric tablets

Curcumin Group

ACTIVE COMPARATOR

Curcumin and Bioperine tablets: Each tablet contains 1,000mg Curcumin + 1.25mg black pepper. Dose: subjects will take 6 tablets per day, with a total dose of 6,000mg curcumin. Supplied by Sabinsa corporation

Dietary Supplement: Curcumin and Bioperine tablets

Placebo Group

PLACEBO COMPARATOR

Placebo tablets made to look like the turmeric and curcumin tablets Each placebo tablet will contain: microcrystalline cellulose, dicalcium phosphate, PVPK30, sodium starch glycolate, magnesium stearate, OpaDry orange coating. Dose: subjects in this group will take 6 placebo tablets per day

Dietary Supplement: Placebo tablets

Interventions

Turmeric tabletsDIETARY_SUPPLEMENT
Turmeric group
Curcumin and Bioperine tabletsDIETARY_SUPPLEMENT
Curcumin Group
Placebo tabletsDIETARY_SUPPLEMENT
Placebo Group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.
  • Those who used topical medications in the past two weeks or systemic antibiotics or oral probiotics within one month of starting the study.
  • Subjects who are postmenopausal
  • Those who are pregnant or breastfeeding.
  • Those that are prisoners or cognitively impaired.
  • Those who have a known allergy to black pepper should not participate in this clinical trial, since one of the treatments consists of tablets containing a small amount (1.25mg/tablet) of black pepper.
  • Those that are taking angiotensin converting enzyme inhibitor medications or angiotensin receptor blocker medications for any reason.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, Davis Dermatology Clinical Trials Unit

Sacramento, California, 95816, United States

Location

Related Publications (2)

  • 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.

    PMID: 17569219BACKGROUND

  • 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.

    PMID: 12676044BACKGROUND

MeSH Terms

Conditions

Dermatitis

Interventions

Curcumin

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

DiarylheptanoidsHeptanesAlkanesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, Cyclic

Study Officials

  • Raja K Sivamani, M.D.

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2016

First Posted

February 28, 2017

Study Start

November 30, 2016

Primary Completion

August 28, 2017

Study Completion

August 28, 2017

Last Updated

December 19, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)