Effect of a Facial Cream Containing Cannabidiol and Hemp Oil on Skin Hydration and Acne-prone Skin
NCT ID: NCT04045119
Last Updated: 2020-04-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
54 participants
INTERVENTIONAL
2019-10-01
2020-01-02
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluating Microneedling With CBD and Hempseed Oil for Acne Vulgaris Safety and Efficacy
NCT06362889
Full Spectrum Hemp Observational Study
NCT04730414
A Botanical Skin Care Regimen on Mild to Moderate Acne and the Microbiome
NCT05271487
Double-blinded, Vehicle Controlled Study to Evaluate Efficacy & Tolerance of Bakuchiol and Ethyl Linoleate on Acne
NCT05069272
Study to Investigate the Efficacy and Safety of Cannabis Oil for the Treatment of Subjects With Hidradenitis Suppurativa
NCT03929835
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Healthy adults will be invited to participate and the general characteristics of the product will be explained, as well as the amount of time that will be required. The individuals that agree to participate will have to read and sign the informed consent, register contact information, and will be scheduled for visit 0 at the research center within 2 to 7 days. During this period (i.e., washout period), the subject will be told not to use abrasive cleansing products or topical medicines on the facial skin, not to take more than one shower per day, and not to consume caffeine or alcohol 24 hours before attending the research center.
During the washout period the subject will receive a call to confirm compliance with washout requirements as well as visit 0 schedule. If washout conditions are not met, subject will be reminded to comply and visit will be re-scheduled within 2 to 7 days.
In visit 0 at the research center, contact information, demographic variables and standard anthropometric variables will be recorded. Subsequently, the subject will be given detailed information about the research product and protocol, accompanied by an information leaflet with indications regarding the use of the investigational product as well as recommendations on preferred hygiene regimens.
The subject will be able to review the material in a room under controlled ventilation, temperature, humidity and lighting conditions, where he or she will have to stay for a minimum of 30 minutes. After that, in an adjacent room under the same conditions, the basal characteristics of the facial skin will be measured through electrical and photometric variables as well as self-assessment of oily skin, a standardized photograph with visual assessment and self-image questionnaire (i.e., hour 0). The bioengineering measurements will be made on the cheeks (i.e., between the base of the ear lobe and the apex of the chin) and forehead (i.e., exact center of the forehead) and no marking of the measurement area will be performed.
Once this process is done, the subject goes back to the waiting room, where a research assistant explains how to apply the investigational product on the face and evaluate the product characteristics. The subject applies the product and evaluates its characteristics. 10 minutes after application, the subject will complete a perception survey about the product characteristics sensation produced on the skin. Afterwards, the subject may leave the room under controlled conditions; however, he or she must return 30 minutes prior to the next measurements.
One hour after the application of the topical product (including 30 minutes of acclimatization in the room under controlled conditions), a new measurement of the electrical, photometric and colorimetric variables as well as self-assessment of oily skin and a standardized photograph with visual assessment is made. This procedure is repeated after 3 hours (including 30 minutes of acclimatization in the room under controlled conditions). Once the last measurement is made the subject completes the last part of the survey and is given a vessel containing the investigational product and instructions regarding its usage will be reinforced. Additionally, schedule for next visit will be determined at this time.
The subject must apply the product according to the indications and keep a journal of the applications. Additionally, the subject must refrain from using other topical products on the volar forearm or systemic products that may alter the skin conditions. Furthermore, there will be a follow-up call to remind the participant to comply with the requirements and confirm schedule next visit.
Two weeks after visit 0, the subject will return to the research center, where a new measurement of the electrical, photometric and colorimetric variables as well as self-assessment of oily skin, a standardized photograph with visual assessment and self-image questionnaire is made. This procedure is repeated by the 4th week, additionally, the subject will answer the last part of the perception survey in this visit. Once this is completed the product application phase will be terminated and the amount of remaining product as well as any significant journal entries will be registered at this point.
Throughout the study there will be tolerance and safety monitoring in every visit and follow-up call, as follows: Upon first application of the investigational product there will be an observation of the subject during a 15-minute period done by the research staff, a physician will be available to assess any possible allergic reaction or significant irritation.
The research staff will examine the application site of the research product to find potential local reactions and will ask about any systemic symptom. If no adverse reactions occur, the information will be recorded. Similarly, if any adverse reaction, systemic reaction or adverse event occurs it will be recorded and the physician will take the necessary measures to ensure subject safety according to his expert judgement and initiate event reporting according to applicable regulation. Finally, in every phone call made by the call center, adherence and tolerance questions will be made and recorded.
At the 5th week, the subject will receive a final follow-up call to record any events that might have appeared after removing the product, thus ending follow-up phase
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Before-and-after
54 Healthy adults 18 years of age or older at the visit or will receive the first application and will be evaluated according to the objectives defined in the study (short-term data) and to evaluate the longterm effects, two other visits will be made at intervals of 2 weeks to evaluate the impact of topical skin application according to the parameters defined in the study
Topical Moisturizer
The investigational product is a moisturizing facial cream for skin with imperfections that is applied topically and is manufactured by Avicanna Inc. This preparation contains widely used ingredients from mineral and botanical origin aimed at improving skin hydration and characteristics associated acne-prone skin. The moisturizer also contains 0.1% of hemp oil rich in essential fatty acids and antioxidants and 0.5% of cannabidiol with regulatory effect on the skin.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Topical Moisturizer
The investigational product is a moisturizing facial cream for skin with imperfections that is applied topically and is manufactured by Avicanna Inc. This preparation contains widely used ingredients from mineral and botanical origin aimed at improving skin hydration and characteristics associated acne-prone skin. The moisturizer also contains 0.1% of hemp oil rich in essential fatty acids and antioxidants and 0.5% of cannabidiol with regulatory effect on the skin.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Oily or acne-prone skin as defined by self-assessment
* Accepts and signs the informed consent.
Exclusion Criteria
* Subjects with a chronic disease that requires medication
* Subjects with known diagnosis of cancer
* Smoking habit or alcohol consumption habit (i.e., once a day or more)
* Recreational or medicinal use of cannabinoids
* Skin diseases (i.e., diseases that require care of a dermatologist)
* Current medication uses such as: Immunomodulators, antibiotics, corticoids or retinoids
* Hypersensitivity to any component of the research product
* Involvement in other clinical or cosmetic studies in the last 6 months
* Recent exposure to sun causing sun tanning (i.e., as reported by the subject causing discomfort or change in the usual appearance of the skin)
* Permanent decoration of the skin in the test area
18 Years
70 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Avicanna Inc
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Maria A Granados, MD., MSc.
Role: PRINCIPAL_INVESTIGATOR
Centro de Atencion e Investigacion Medica
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
VITA
Chía, Cundinamarca, Colombia
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Kapoor S, Saraf S. Assessment of viscoelasticity and hydration effect of herbal moisturizers using bioengineering techniques. Pharmacogn Mag. 2010 Oct;6(24):298-304. doi: 10.4103/0973-1296.71797.
Poli F, Dreno B, Verschoore M. An epidemiological study of acne in female adults: results of a survey conducted in France. J Eur Acad Dermatol Venereol. 2001 Nov;15(6):541-5. doi: 10.1046/j.1468-3083.2001.00357.x.
Arbuckle R, Clark M, Harness J, Bonner N, Scott J, Draelos Z, Rizer R, Yeh Y, Copley-Merriman K. Item reduction and psychometric validation of the Oily Skin Self Assessment Scale (OSSAS) and the Oily Skin Impact Scale (OSIS). Value Health. 2009 Jul-Aug;12(5):828-37. doi: 10.1111/j.1524-4733.2009.00504.x.
Segot-Chicq E, Compan-Zaouati D, Wolkenstein P, Consoli S, Rodary C, Delvigne V, Guillou V, Poli F. Development and validation of a questionnaire to evaluate how a cosmetic product for oily skin is able to improve well-being in women. J Eur Acad Dermatol Venereol. 2007 Oct;21(9):1181-6. doi: 10.1111/j.1468-3083.2007.02193.x.
Biro T, Toth BI, Hasko G, Paus R, Pacher P. The endocannabinoid system of the skin in health and disease: novel perspectives and therapeutic opportunities. Trends Pharmacol Sci. 2009 Aug;30(8):411-20. doi: 10.1016/j.tips.2009.05.004. Epub 2009 Jul 14.
Kupczyk P, Reich A, Szepietowski JC. Cannabinoid system in the skin - a possible target for future therapies in dermatology. Exp Dermatol. 2009 Aug;18(8):669-79. doi: 10.1111/j.1600-0625.2009.00923.x.
Citti C, Pacchetti B, Vandelli MA, Forni F, Cannazza G. Analysis of cannabinoids in commercial hemp seed oil and decarboxylation kinetics studies of cannabidiolic acid (CBDA). J Pharm Biomed Anal. 2018 Feb 5;149:532-540. doi: 10.1016/j.jpba.2017.11.044. Epub 2017 Nov 20.
Mikulcova V, Kasparkova V, Humpolicek P, Bunkova L. Formulation, Characterization and Properties of Hemp Seed Oil and Its Emulsions. Molecules. 2017 Apr 27;22(5):700. doi: 10.3390/molecules22050700.
Eccles M, Grimshaw J, Campbell M, Ramsay C. Research designs for studies evaluating the effectiveness of change and improvement strategies. Qual Saf Health Care. 2003 Feb;12(1):47-52. doi: 10.1136/qhc.12.1.47.
Tsai TH, Chuang LT, Lien TJ, Liing YR, Chen WY, Tsai PJ. Rosmarinus officinalis extract suppresses Propionibacterium acnes-induced inflammatory responses. J Med Food. 2013 Apr;16(4):324-33. doi: 10.1089/jmf.2012.2577. Epub 2013 Mar 20.
Rawlings AV, Canestrari DA, Dobkowski B. Moisturizer technology versus clinical performance. Dermatol Ther. 2004;17 Suppl 1:49-56. doi: 10.1111/j.1396-0296.2004.04s1006.x.
Petry T, Bury D, Fautz R, Hauser M, Huber B, Markowetz A, Mishra S, Rettinger K, Schuh W, Teichert T. Review of data on the dermal penetration of mineral oils and waxes used in cosmetic applications. Toxicol Lett. 2017 Oct 5;280:70-78. doi: 10.1016/j.toxlet.2017.07.899. Epub 2017 Aug 5.
Reuter J, Merfort I, Schempp CM. Botanicals in dermatology: an evidence-based review. Am J Clin Dermatol. 2010;11(4):247-67. doi: 10.2165/11533220-000000000-00000.
Iffland K, Grotenhermen F. An Update on Safety and Side Effects of Cannabidiol: A Review of Clinical Data and Relevant Animal Studies. Cannabis Cannabinoid Res. 2017 Jun 1;2(1):139-154. doi: 10.1089/can.2016.0034. eCollection 2017.
Darlenski R, Sassning S, Tsankov N, Fluhr JW. Non-invasive in vivo methods for investigation of the skin barrier physical properties. Eur J Pharm Biopharm. 2009 Jun;72(2):295-303. doi: 10.1016/j.ejpb.2008.11.013. Epub 2008 Dec 11.
Loden M. The clinical benefit of moisturizers. J Eur Acad Dermatol Venereol. 2005 Nov;19(6):672-88; quiz 686-7. doi: 10.1111/j.1468-3083.2005.01326.x.
Parente ME, Gambaro A, Solana G. Study of sensory properties of emollients used in cosmetics and their correlation with physicochemical properties. J Cosmet Sci. 2005 May-Jun;56(3):175-82.
Lukic M, Jaksic I, Krstonosic V, Cekic N, Savic S. A combined approach in characterization of an effective w/o hand cream: the influence of emollient on textural, sensorial and in vivo skin performance. Int J Cosmet Sci. 2012 Apr;34(2):140-9. doi: 10.1111/j.1468-2494.2011.00693.x. Epub 2011 Dec 6.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Av 0002 DaCol
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.