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Efficacy and safety of skin care approach in the treatment of keratosis pilaris

Efficacy and safety of skin care approach in the treatment of keratosis pilaris: a randomized controlled clinical trial study protocol

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN14455606
Enrollment
72
Registered
2025-04-06
Start date
2024-04-15
Completion date
Unknown
Last updated
2026-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Keratosis pilaris Skin and Connective Tissue Diseases

Interventions

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 resear

Sponsors

Beijing Technology & Business University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
The number of follicular papules was recorded by dermatoscope, and the improvement index of follicular papules was calculated at baseline, 7,14,21,and 28 day.

Secondary

MeasureTime frame
The skin roughness (SEr), smoothness (SEsm), and scaling index (SEsc) were measured using the skin microscope Visioscan® VC98 at baseline, 7,14,21,and 28 day.

Countries

China

Contacts

Public ContactHong Meng
menghong2000@163.com+86 13691589617

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 14, 2026