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Completed

NCT Number: NCT07752368

A Clinical Trial Examining the Efficacy of a Novel Acne Treatment Serum

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.

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Key information

Conditions

Acne Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin Health Skin and Connective Tissue Diseases

Age range

24 year–47 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Citruslabs

Las Vegas, Nevada, 89101, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acne Treatment Serum

Dietary Supplement

All enrolled participants receive the Cool as a Cucumber Acne Treatment Serum (30ml bottle, active ingredient: Salicylic Acid 0.5%) applied topically as directed.

Primary outcomes

  1. Change in Facial Acne Symptoms

    Time frame: 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

  2. Change in Facial Acne Severity on Photographs

    Time frame: 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 outcomes

  1. Change in Skin Texture

    Time frame: Baseline, Week 4, and Week 8

    Self-reported change in skin texture assessed via study-specific questionnaire

  2. Change in Skin Tone

    Time frame: Baseline, Week 4, and Week 8

    Self-reported change in uneven skin tone assessed via study-specific questionnaire

  3. Change in Hyperpigmentation

    Time frame: Baseline, Week 4, and Week 8

    Self-reported change in hyperpigmentation assessed via study-specific questionnaire

  4. Change in Redness/Inflammation

    Time frame: Baseline, Week 4, and Week 8

    Self-reported change in redness and inflammation assessed via study-specific questionnaire

  5. Change in Sebum Production

    Time frame: Baseline, Week 4, and Week 8

    Self-reported change in sebum production assessed via study-specific questionnaire

  6. Change in Fine Lines and Wrinkles

    Time frame: Baseline, Week 4, and Week 8

    Self-reported change in fine lines and wrinkles assessed via study-specific questionnaire

Sponsors and collaborators

Lead sponsor

Parea INC dba Cool as a Cucumber

Industry

Collaborators

  • Citruslabs

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Aug 7, 2026
Registry last updated
Aug 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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