Efficacy and safety of skin care approach in the treatment of keratosis pilaris: a randomized controlled clinical trial study protocol
Keratosis pilaris
In this experiment, the randomization method of drawing lots was employed. After all patients were numbered, group numbers were randomly drawn to assign them to different groups for therapeutic research. The treatment group underwent a comprehensive skin care intervention. Specifically, the upper arms were massaged with moderate pressure. Each arm was then treated with an almond acid scrub for 20-30 seconds, followed by thorough rinsing. Subsequently, a ceramide-based compound body lotion was applied. After rinsing and drying the body, a matching body lotion was applied to the same upper arm, with at least one pump used per arm and massaged thoroughly until fully absorbed. The control group was treated with 0.1% tretinoin cream. First, the local skin was cleaned using a gentle soap and then gently patted dry. A waiting period of 20-30 minutes was observed to ensure the skin was completely dry. After washing hands, gloves or finger cots were worn to prevent direct contact between the medication and the skin of the hands. An appropriate amount of cream (depending on the size of the affected area) was taken with the fingertip or a cotton swab and applied from the center of the affected area, spreading outward in a clockwise or counterclockwise circular motion. The application site was gently massaged to facilitate full absorption of the medication until the cream completely disappeared.
1. Chinese participants aged 18 to 55 years, who meet the diagnostic criteria for keratosis pilaris. 2. Willing to undergo treatment and complete the course, attend follow-up visits on schedule for photography, and sign an informed consent form.
1. Patients with severe organic diseases of important organs such as cardiovascular and cerebrovascular diseases, diabetes, liver and kidney diseases, bleeding disorders, and severe primary hematologic diseases, as well as patients with mental illness. 2. Patients allergic to mandelic acid or other test drugs. 3. Patients with active viral diseases such as herpes simplex or warts at the treatment site, or those who have undergone cryotherapy, radiotherapy, phototherapy, or surgery in the past six months. 4. Patients who have taken oral corticosteroids within the past three months. 5. Patients with immunodeficiency diseases or a history of keloid formation. 6. Patients who are currently participating in or have participated in other clinical studies/treatments within the past three months. 7. Women who are planning to conceive, pregnant, or breastfeeding. 8. Patients whose medical history, physical examination, and laboratory tests can rule out keratosis pilaris secondary to other diseases.