Acne, Acne Vulgaris, Skin Health
Conditions
Brief summary
This single-group, open-label clinical trial examines the efficacy of Cool as a Cucumber's Acne Treatment Serum in adults with acne-prone skin. The study will enroll 25 male and female participants between the ages of 24 and 47 who will use the serum for eight weeks, with assessments conducted virtually at Baseline, Week 4, and Week 8. The primary objective is to evaluate the effects of the Acne Treatment Serum on facial acne using the Validated Acne Quality-of-Life Scale (Acne QoL) and expert-graded before-and-after photographs. Secondary objectives include evaluating changes in skin texture, uneven skin tone, hyperpigmentation, redness, sebum production, and fine lines and wrinkles via self-reported questionnaires.
Interventions
DIETARY_SUPPLEMENTAcne Treatment Serum
All enrolled participants receive the Cool as a Cucumber Acne Treatment Serum (30ml bottle, active ingredient: Salicylic Acid 0.5%) applied topically as directed.
Sponsors
Parea INC dba Cool as a Cucumber
Citruslabs
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
24 Years to 47 Years
Healthy volunteers
No
Inclusion criteria
* Male or female between the ages of 24-47 (between 2-4 males, the remainder females) * Actively has acne (non-inflamed and/or inflamed acne) * Has previously used or is currently using exfoliating acids (AHAs / BHA) and is willing to stop this for the duration of the study * Has not experienced sunburn on the face in the last month * No open wounds, sores, or non-acne related lesions on the face * Generally healthy - don't live with any uncontrolled chronic disease * Willing to apply SPF on a daily basis during the study and to use other sun protection on the face (i.e. a hat) * Must be willing to avoid products with coconut oil and shea butter, and Ethylhexyl Palmitate for the duration of the study * Must be willing to cut out whey protein and cow's milk from their diet for the duration of the study * Must be willing to avoid biotin products or supplements for the duration of the study * Must agree to avoid sun tanning, tanning beds, and self-tanning products for the duration of the study
Exclusion criteria
* Any pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders * Anyone with known severe allergic reactions * Women who are pregnant, breastfeeding or attempting to become pregnant * Unwilling to follow the study protocol * Smoker * Anyone consuming products containing Tetrahydrocannabinol (THC) * Identifies as a person with sensitive skin * Anyone currently on steroids or undergoing hormone replacement therapy * Anyone using prescription medication relevant to the skin * Undergoing any cosmetic procedures during the study including facials, Botox, dermal filler, laser, or chemical peel treatments * Use of prescription drug (topical or oral) that is targeted at any sort of skin condition (e.g., retinoids, accutane) * Anyone allergic to niacinamide or salicylic acid * Anyone who regularly consumes biotin supplements and is unwilling to stop for the duration of the study * Participants who stopped using birth control within the past 3 months * Participants currently have a Copper IUD or are using one of the following birth control high in androgen and low in estrogen activity: Amethyst, Jolessa, Lessina, Levonest/Levora, Lutera, Nordette, Portia, Seasonale/Seasonique, Sronyx, Mirena IUD, Triphasil/Trivora, Cryselle, Lo-Ovral/Ovral, Low-Ogestrel/Ogestrel, Lo-Feminol, Ortho tricyclen Lo, Estrostep Fe, Loestrin, Microgestin, Apri, Mircette, Azurette, Caziant, Cyclessa, Desogen, Emoquette, Kariva, Linessa, Marvelon, NuvaRing, Depo-Provera, Reclipsen
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Facial Acne Symptoms | Baseline, Week 4, and Week 8 | Mean change in perceived facial acne symptoms assessed via the Validated Acne Quality-of-Life Scale (Acne QoL) self-reported questionnaire |
| Change in Facial Acne Severity on Photographs | Baseline, Week 4, and Week 8 | Expert skin grading by a dermatologist of before-and-after selfie photographs to assess visual changes in acne severity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Skin Texture | Baseline, Week 4, and Week 8 | Self-reported change in skin texture assessed via study-specific questionnaire |
| Change in Skin Tone | Baseline, Week 4, and Week 8 | Self-reported change in uneven skin tone assessed via study-specific questionnaire |
| Change in Hyperpigmentation | Baseline, Week 4, and Week 8 | Self-reported change in hyperpigmentation assessed via study-specific questionnaire |
| Change in Redness/Inflammation | Baseline, Week 4, and Week 8 | Self-reported change in redness and inflammation assessed via study-specific questionnaire |
| Change in Sebum Production | Baseline, Week 4, and Week 8 | Self-reported change in sebum production assessed via study-specific questionnaire |
| Change in Fine Lines and Wrinkles | Baseline, Week 4, and Week 8 | Self-reported change in fine lines and wrinkles assessed via study-specific questionnaire |
Countries
United States
Outcome results
None listed