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Recruiting
NCT05756881
Topical Palm Tocotrienols on Blemish-prone Skin
Conditions: Acne
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: 1
Phase: PHASE2
Enrollment: 110
Sponsor: Universiti Sains Malaysia
Location: Malaysia
Summary
A single-center, double-blind, randomised, placebo-controlled parallel-group study.Selected subjects will be randomised into active and control groups in a ratio of 1:1.
Investigational products assigned will be applied on the facial skin as part of daily skin care routine.
The effects will be observed during the 12-weeks of use.
Eligibility Criteria
Inclusion Criteria:Healthy individuals, aged 18 years and aboveFitzpatrick skin type II to IVBlemish-prone skin with acne of severity grade 2 or 3 based on Comprehensive Acne Severity Scale (CASS)Exclusion Criteria:Has a history of chronic drug or alcohol abuseIs a current smokerHistory of severe allergic reactions to topical products or vitamin EParticipant with severe and uncontrollable comorbidities (including but not limited to e.g.
diabetes, hypertension, kidney failure)Pregnant, breastfeeding, or planning pregnancyParticipant with known skin conditions (including but not limited to e.g.
sensitive skin, eczema and diseased skin e.g.
contact dermatitis), uncontrolled medical conditions, or any other condition that could interfere with the study evaluations or increase risk to the participant (such as polycystic ovary syndrome and contact dermatitis)Participant with compromised/broken skin, tattoos, scarring, excessive hair growth, very uneven skin tone, or other conditions that would interfere with evaluations or increase riskParticipation in another study within 4 weeks of screening visitHas severe acne or acne conglobataUse of systemic treatment for acne such as isotretinoin, contraceptive pills, or spironolactone within 4 weeks of screening visitUse of topical treatments like antibiotics, corticosteroids, benzoyl peroxide, azelaic acid, salicylic acid, alpha hydroxy acids (AHAs), vitamins A (retinol) or C (ascorbic acid) or their analogs or derivatives and other anti-inflammatory drugs within 2 weeks of screening visitUse of scrub, alpha-hydroxy acid (AHA), skin irritant products in the 2 days before study treatment startParticipant with active bacterial/fungal/viral skin infections or susceptibility to such infections within 2 weeks of Screening visitUse oral antibiotics
Source: ClinicalTrials.gov (NCT05756881). StuddyBuddy aggregates publicly available trial information.