Health Condition 1: L700- Acne vulgaris
Conditions
Interventions
Intervention1: Salicylic acid based exfoliating cleanser and moisturizer regimen: Topical application of a salicylic acid based exfoliating cleanser followed by moisturizer containing AHA, BHA, and PH
Sponsors
CUTIS Academy of Cutaneous Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 1.Adult subjects with oily skin or combination skin, including oily T zone. 2.Subjects with acne prone skin having ten or more non inflammatory acne lesions such as open comedones and closed comedones on the full face excluding the nose and scalp edge, and having at least one inflammatory lesion and not more than ten inflammatory lesions such as papules. 3.Female or male subjects aged between eighteen and sixty years, with efforts made to include a range of ages. 4.Subjects in good general health, including physical, mental, and social well being, and not merely the absence of disease or infirmity, based on medical history or general health screening questionnaire. 5.Subjects having Fitzpatrick skin type three to five. 6.Subjects willing to document product applications including dates and locations of any topical applications. 7.Adult male subjects with affected area on the face or neck must shave regularly at least three times per week and must not have a beard. A mustache or small goatee is allowed if most of the face and neck is shaved. 8.Subjects willing to stop using cleanser and moisturizing products on the test area and to use only the provided test product for the duration of the study. 9.Subjects willing to sign a photography release form. 10.Subjects with affected area on the face must not have undergone any facial treatments in the past six months and must agree to avoid such treatments during the study. These include facials, facial peels, photofacials, laser treatments, dermabrasion, botulinum toxin treatments, injectable filler treatments, intense pulsed light treatments, acid treatments, skin tightening procedures, facial plastic surgery, or any similar procedures performed by a physician or skin care professional. Waxing and threading are allowed, but facial laser hair removal is not allowed. 11.Subjects qualifying for facial assessment must agree not to apply facial makeup on the day of study visits. 12.Subjects willing and able to comply with all study procedures and requirements. 13.Subjects willing to discontinue all other medications and products except those permitted or prescribed in the study as per investigator discretion.
Exclusion criteria
Exclusion criteria: 1.Subjects who have used Class one to Class three topical corticosteroids within the last four weeks prior to the screening visit. 2.Subjects who have used systemic corticosteroids within the last one week prior to the screening visit. 3.Subjects who have used oral isotretinoin within six months prior to the screening visit. 4.Subjects who have undergone phototherapy within the last four weeks prior to the screening visit. 5.Subjects who have used topical retinoids on the test area within the last six months prior to the screening visit. 6.Presence of scarring, tattoos, or any other skin condition that may impact the study results. 7.Subjects with known allergies to facial or body skin care products. 8.Subjects who are breastfeeding, pregnant or planning to become pregnant during the study based on subject self report. 9.Subjects with a history of skin cancer within the past five years. 10.Subjects with clinically active bacterial, fungal or viral skin infections or a history of such infections, based on subject self report. 11.Subjects who have used systemic immunosuppressive or immunomodulator medications or treatments within the past four weeks that may interfere with the study objectives as per investigator discretion. 12.Subjects with a health condition or pre existing or dormant dermatologic disease on the test area, such as psoriasis, rosacea, moderate to severe acne, acne conglobata, nodules or cysts, seborrheic dermatitis or severe excoriations, that in the opinion of the investigator or designee may interfere with study outcomes or make participation unsuitable. 13.Subjects with observable sunburn, suntan, scars, nevi, excessive hair, tattoos, or other dermal conditions on the test area that may influence test results, as per investigator or designee opinion. 14.Subjects with a history of immunosuppression or immune deficiency disorders, including human immunodeficiency virus infection, acquired immunodeficiency syndrome, multiple sclerosis, Crohn disease, or rheumatoid arthritis, history of organ transplant such as heart or kidney, or current use of systemic immunosuppressive medications, radiation, or chemotherapy, as per study records. 15.Subjects who have used biologic treatments within the past twelve weeks, unless a washout period of twelve weeks has been completed prior to participation. 16.Subjects with uncontrolled diseases such as asthma, diabetes, epilepsy, hypertension, hyperthyroidism, or hypothyroidism. Subjects with multiple medical conditions may be excluded even if controlled, as per investigator discretion. 17.Subjects with any planned surgeries, hospitalizations, or invasive medical procedures during the study. Non invasive procedures will be evaluated for impact and acceptability by the investigator or designee. 18.Subjects who have started hormone replacement therapy or hormonal contraceptives within three months prior to enrollment or who plan to start, stop or change doses during the study. 19.Subjects who have received any medical treatment within one week prior to study start that may increase risk or affect study outcomes, as per investigator discretion. 20.Subjects who have undergone surgical, chemical or physical treatment to the test area within the last twelve months, or within twenty four months for liposuction. 21.Subjects who have applied any cosmetic produ
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in skin hydration measured using Corneometer CM 825Timepoint: Baseline (Day 0), Week 2, Week 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in skin sebum levels measured using Sebumeter SM 815 Change in acne lesion counts (non-inflammatory and inflammatory) Change in Investigator s Global Assessment (IGA) score Change in skin parameters assessed by skin analyzer (UV moisture, pigmentation, UV damage) Subject-reported outcomes using Oily Skin Impact Scale (OSIS) Safety assessment based on incidence of adverse events and local tolerability (erythema, dryness, scaling, stinging)Timepoint: Baseline (Day 0), Week 2, Week 4 | — |
Countries
India
Contacts
Public ContactDr B S Chandrashekar
CUTIS Academy of Cutaneous Sciences
Outcome results
None listed