Cosmetic Acne Clinical Trial
— DahliaOfficial title:
Effect of a Facial Cream Containing 0.5% Cannabidiol and 0.1% Hemp Oil on Skin Hydration and Characteristics Associated Acne-prone Skin
Verified date | April 2020 |
Source | Avicanna Inc |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This research seeks to evaluate the short (i.e., after single application) and long-term (i.e., after periodic application) hydrating effect of a topical preparation containing CBD and hemp oil on facial skin as well as the effect on erythema, appearance, instrumentally measured sebum production and quality of life.
Status | Completed |
Enrollment | 54 |
Est. completion date | January 2, 2020 |
Est. primary completion date | January 2, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Eligibility criteria Healthy adult men and women with oily skin from the municipality of
Chia and neighboring communities. Inclusion criteria: - Adult (i.e., over 18 years old) men or women. - Oily or acne-prone skin as defined by self-assessment - Accepts and signs the informed consent. Exclusion criteria - Pregnant or breast-feeding women - 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 |
Country | Name | City | State |
---|---|---|---|
Colombia | VITA | Chia | Cundinamarca |
Lead Sponsor | Collaborator |
---|---|
Avicanna Inc |
Colombia,
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* Note: There are 18 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluate the effect on hydration of a single application of the topical preparation on facial skin | Evaluate the effect on hydration of a single application of the topical preparation on facial skin, through the direct measurement of its electrical properties as an indicator of water content at 1 and 3 hours. Measurement of the water content of the stratum corneum by capacitance. | Change from baseline at 1 and 3 hours | |
Primary | Evaluate the effect on hydration of periodic application of the topical preparation on facial skin | Evaluate the effect on hydration of periodic application of the topical preparation on facial skin, through the direct measurement of its electrical properties as an indicator of water content at 2 and 4 weeks. Measurement of the water content of the stratum corneum by capacitance. | Change from baseline at 2 and 4 weeks | |
Secondary | Evaluate the short-term change in instrumentally assessed measurement of oily skin | Evaluate the short-term change in instrumentally assessed measurement of oily skin (i.e., 1 and 3 hours), through photometrical transparency change of a translucent plastic strip. | Change from baseline at 1 and 3 hours | |
Secondary | Evaluate the long-term change in instrumentally assessed measurement of oily skin | Evaluate the long-term change in instrumentally assessed measurement of oily skin (i.e., 2 and 4 weeks), through photometrical transparency change of a translucent plastic strip. | Change from baseline at 2 and 4 weeks | |
Secondary | Evaluate the short-term change in instrumentally measured skin biochromophores | Evaluate the short-term change in instrumentally measured skin biochromophores (i.e., 1 and 3 hours) | Change from baseline at 1 and 3 hours | |
Secondary | Evaluate the long-term change in instrumentally measured skin biochromophores | Evaluate the long-term change in instrumentally measured skin biochromophores (i.e., 2 and 4 weeks) | Change from baseline at 2 and 4 weeks | |
Secondary | Evaluate the short-term effect (i.e., 1 and 3 hours) of this topical preparation on subjective assessment of oily skin | Evaluate the short-term effect (i.e., 1 and 3 hours) of this topical preparation on subjective assessment of oily skin, through the application of a validated questionnaire. Subjects will evaluate the degree of oiliness in a visual analog scale of 0 to 10 (i.e., 0: normal skin; 10: very severe oiliness) | Change from baseline at 1 and 3 hours | |
Secondary | Evaluate the long-term effect (i.e., 2 and 4 weeks) of this topical preparation on subjective assessment of oily skin | Evaluate the long-term effect (i.e., 2 and 4 weeks) of this topical preparation on subjective assessment of oily skin, through the application of a validated questionnaire Subjects will evaluate the degree of oiliness in a visual analog scale of 0 to 10 (i.e., 0: normal skin; 10: very severe oiliness) | Change from baseline at 2 and 4 weeks | |
Secondary | Evaluate the short-term effect (i.e., 1 and 3 hours) of this topical preparation on the skin appearance | Evaluate the short-term effect (i.e., 1 and 3 hours) of this topical preparation on the skin appearance, trough standardized photography and investigator evaluation. Subjects will be assessed by the investigation staff in comparison with baseline as follows: Almost clear if 90-99% clearance is observed Marked improvement if 75-89% clearance is observed Moderate improvement if 50-74% clearance is observed Minimal improvement if 25-49% clearance is observed No change if 0-24% clearance from baseline is observed | Change from baseline at 1 and 3 hours | |
Secondary | Evaluate the long-term effect (i.e., 2 and 4 weeks) of this topical preparation on the skin appearance | Evaluate the long-term effect (i.e., 2 and 4 weeks) of this topical preparation on the skin appearance, trough standardized photography and investigator evaluation. Subjects will be assessed by the investigation staff in comparison with baseline as follows: Almost clear if 90-99% clearance is observed Marked improvement if 75-89% clearance is observed Moderate improvement if 50-74% clearance is observed Minimal improvement if 25-49% clearance is observed No change if 0-24% clearance from baseline is observed | Change from baseline at 2 and 4 weeks | |
Secondary | Evaluate the long-term effect (i.e., 2 and 4 weeks) of this topical preparation on quality of life | Evaluate the long-term effect (i.e., 2 and 4 weeks) of this topical preparation on quality of life, through the application of a standardized self-image questionnaire. The OSSIQ questionnaire will be used to perform self-image assessment by the subject using a five-point scale (never 0, rarely 1, sometimes 2, often 3, and always 4) to score 18 questions. | Change from baseline at 2 and 4 weeks | |
Secondary | Evaluate the short and long-term emollient effect and acceptance of this topical preparation | Evaluate the short and long-term emollient effect and acceptance of this topical preparation, through the application of a perception survey (i.e., 0 hours, 1 hours and 4 weeks). Perceived skinfeel attributes of creams and lotions (appearance, rub-in, absorption, appearance of skin, immediate and delayed after-feel) have been evaluated using a trained descriptive panel. In previously published studies researchers used the skinfeel spectrum descriptive analysis method to characterize skin care products. They used strict protocols for manipulation and precisely defined terms to describe the qualitative properties and their relative intensities in each product. The evaluation process was divided into four categories: pick-up (i.e., firmness, stickiness, cohesiveness, peaking); rub-out (i.e., wetness, spreadability, thickness, absorbency); residual feel; and appearance, immediate and after 20 minutes (i.e., glossy, sticky, slippery, oily, waxy, greasy | 0 hours, 1 hour, and 4 weeks | |
Secondary | Evaluate the short and long-term tolerance of this topical preparation | Evaluate the short and long-term tolerance of this topical preparation, through the application of a perception survey. This is scored by investigators using a four-point scale: absent, mild, moderate and severe. | 0 hours, 1 hour, and 4 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04249128 -
Nourishing Hair, Skin & Nails Supplement Study (Derm Aid)
|
Phase 3 |