Skin aging Skin and Connective Tissue Diseases
Conditions
Interventions
Split face 1-year clinical trial, half-face rotating 2 formulas (various active ingredients) every 7 days compared to other side without treatment.
Prior to the start of the study, Stephens Lab will
the other formulated with a combination of phytol and glycolic acid. Subjects who meet enrollment criteria are instructed to apply the test article to a randomly-assigned half of their face each night
Sponsors
Avon (United States)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women in good health 2. Skin type I-IV who presented mild to moderate signs of photodamage on both sides of their faces, scores 3-6 to qualify on 0-9 scale (modified Griffiths scale)
Exclusion criteria
Exclusion criteria: 1. Diagnosed with known allergies to facial skin care products or known sensitivities to facial skin care products, sunscreens, or cleansers. 2. Are nursing, pregnant, or planning to become pregnant during the study according to subject self-report. 3. History of skin cancer. 4. Used any of the following medications or had any of the listed procedures within the listed time frame prior to the study start date: 4.1. Retin-A®, Retin-A Micro®, Renova®, Avita®, Tazorac®, Soriatane®, or Differin® within 4 months 4.2. Had a chemical peel, dermabrasion, non-ablative laser or fractional laser resurfacing of the face and neck within 4 weeks 4.3. Accutane® within 12 months 4.4. Prescription strength skin lightening products (e.g. hydroquinone, tretinoin, AHA, BHA and polyhydroxy acids, 4-hydroxyanisole alone or in combination with tretinoin, etc.) within 4 months 4.5. Any anti-wrinkle, skin lightening products, or any other product or topical or systemic medication known to affect skin aging or dyshcromia (products containing alpha/beta/poly-hydroxy acids, vitamin C, soy, Q-10, hydroquinone; systemic or licorice extract (topically), Tego® Cosmo C250, gigawhite, lemon juice extract (topically), emblica extract, etc.) within 2 weeks 4.6. Have undergone a regimen of Thermage treatments or an equivalent type of high energy treatments, plastic surgery, or ablative laser resurfacing of the face and neck within 12 months 4.7. Had facial treatment with a botulinum toxin base injectable (Botox), injectable fillers, or a fat transfer within 6 months 5. Health condition and/or pre-existing or dormant dermatologic disease on the face (e.g., psoriasis, rosacea, acne, eczema, seborrheic dermatitis, severe excoriations etc.) that the Investigator or designee deems inappropriate for participation or could interfere with the outcome of the study. 6. Taking oral to topical antihistamines, anti-inflammatories, or antibiotics. Low-dose aspirin (81 mg daily) is acceptable. 7. Chronic use of systemic steroids within 12 weeks prior to the baseline visit. 8. History of immunosuppression/immune deficiency disorders (including (HIV infection or AIDS) or currently using immunosuppressive medications (e.g., azathioprine, belimumab, cyclophosphamide, Enbrel, Imuran, Humira, mycophenolate mofetil, methotrexate, prednisone, Remicade, Stelara.) and/or radiation as determined by study documentation. 9. An uncontrolled disease such as asthma, diabetes, hypertension, hyperthyroidism, or hypothyroidism. Individuals having multiple health conditions may be excluded from participation even if the conditions are controlled by diet, medication, etc. 10. Any planned surgeries and/or invasive medical procedures during the course of the study. 11. Are currently participating in any other facial usage study or have participated in any facial clinical trial at Stephens or at another research facility or doctor’s office within 4 weeks prior to inclusion into the study. 12. Have observable suntan, sunburn, scars, nevi, excessive hair, etc. or other dermal conditions on the face that might influence the test results in the opinion of the Investigator or designee. 13. Started hormone replacement therapies (HRT) or hormones for birth control less than 3 months prior to study entry or who plan on starting, stopping, or changing doses of HRT or hormones for birth control during the study. 14. Not willing to avoid daily sun exposure on the face and the use of tanning beds or sunless tanning p
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Photoaging parameters measured using a modified Griffiths’ 10-point scale at baseline, and at weeks 4, 8, 12, 18, 24, 36, and 52 (half-point scores may be used as necessary to more accurately describe the skin condition): 0 = none (best possible condition) 1 to 3 = mild 4 to 6 = moderate 7 to 9 = severe (worst possible condition) | — |
Secondary
| Measure | Time frame |
|---|---|
| Tolerability evaluations will be performed at baseline, and weeks 4, 8, 12, 18, 24, 36, and 52. Local cutaneous tolerability will be evaluated by assessing the signs and symptoms of erythema, dryness, and edema, and by subject reporting of the degree of burning, stinging, and itching separately on each subject’s right and left side of the face (treatment area) | — |
Countries
United States of America
Outcome results
None listed