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Background <p>Keratosis pilaris (KP) is a chronic skin disease characterized by keratinized hair follicle papules, typically occurring on the arms, thighs, and buttocks. At present, the external treatment plan for KP is relatively singular. To optimize the existing clinical external drug treatment plan for KP, improve side effects, and enhance patients’ quality of life, we propose the <i>Exfoliate-Dissolve-Repair</i> (EDR) comprehensive skin care method. Based on the EDR concept, we have designed a treatment plan that combines body scrub and moisturizing lotion. This research plan aims to evaluate the safety and efficacy of a novel skincare combination therapy for KP through a randomized controlled trial.</p> Methods <p>This study is a single center, randomized, controlled clinical trial targeting cases of KP aged 18–35&#xa0;years. Participants (<i>n</i> = 72) were randomly assigned to a treatment group and a control group. The treatment group received EDR comprehensive skin care intervention, while the control group received 0.1% retinoic acid cream intervention. The trial includes a 4-week treatment period, with indicator testing and data collection conducted at 7, 14, 21, and 28&#xa0;days after the start of treatment. The main outcome measures include the improvement index of follicular papules and evaluation of skin keratinization degree. Secondary outcome measures include skin moisture content, transdermal moisture loss test, skin elasticity, etc. Use the skin lesion condition, blood pressure, heart rate, heart rhythm, and respiratory rate of the subjects as safety evaluation indicators. Exploratory evaluation of the effectiveness and safety of the EDR comprehensive skin care method for KP.</p> Discussion <p>This study will be the RCT to directly compare the effects of EDR comprehensive skincare approach and 0.1% retinoic acid cream in KP. Findings from the study will provide evidence to inform the clinical management of KP.</p> Trial registration <p>This protocol has been registered prospectively in ISRCTN under the <a href="https://www.isrctn.com/ISRCTN14455606">ISRCTN14455606</a> on April 6, 2025.</p>

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

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年2月24日

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  • Yi-Jie Du,
  • Lu Cheng,
  • Feng-Wei Qi,
  • Jie Yang,
  • Hong Meng

摘要

Background

Keratosis pilaris (KP) is a chronic skin disease characterized by keratinized hair follicle papules, typically occurring on the arms, thighs, and buttocks. At present, the external treatment plan for KP is relatively singular. To optimize the existing clinical external drug treatment plan for KP, improve side effects, and enhance patients’ quality of life, we propose the Exfoliate-Dissolve-Repair (EDR) comprehensive skin care method. Based on the EDR concept, we have designed a treatment plan that combines body scrub and moisturizing lotion. This research plan aims to evaluate the safety and efficacy of a novel skincare combination therapy for KP through a randomized controlled trial.

Methods

This study is a single center, randomized, controlled clinical trial targeting cases of KP aged 18–35 years. Participants (n = 72) were randomly assigned to a treatment group and a control group. The treatment group received EDR comprehensive skin care intervention, while the control group received 0.1% retinoic acid cream intervention. The trial includes a 4-week treatment period, with indicator testing and data collection conducted at 7, 14, 21, and 28 days after the start of treatment. The main outcome measures include the improvement index of follicular papules and evaluation of skin keratinization degree. Secondary outcome measures include skin moisture content, transdermal moisture loss test, skin elasticity, etc. Use the skin lesion condition, blood pressure, heart rate, heart rhythm, and respiratory rate of the subjects as safety evaluation indicators. Exploratory evaluation of the effectiveness and safety of the EDR comprehensive skin care method for KP.

Discussion

This study will be the RCT to directly compare the effects of EDR comprehensive skincare approach and 0.1% retinoic acid cream in KP. Findings from the study will provide evidence to inform the clinical management of KP.

Trial registration

This protocol has been registered prospectively in ISRCTN under the ISRCTN14455606 on April 6, 2025.