RecruitingPhase 4ACTRN12625001406493

Efficacy and Safety of Weekend Topical Mild Corticosteroid Therapy for Maintenance of Seborrheic Dermatitis: A Randomized Controlled Trial

"Efficacy and Safety of Weekend Topical Mild Corticosteroid Therapy for Maintenance of Seborrheic Dermatitis patients: A Randomized Controlled Trial"


Sponsor

Dr Imdad ullah khan, dermatology ward, khyber teaching hospital, peshawar

Enrollment

61 participants

Start Date

Sep 1, 2025

Study Type

Interventional

Conditions

Summary

This study aims to determine whether applying a mild corticosteroid cream only on weekends can help prevent flare-ups of seborrheic dermatitis, a common skin condition that affects the face and scalp. After a short treatment to bring the condition under control, participants will be randomly assigned to either continue using the corticosteroid lotion on weekends, along with antifungal shampoo 2/3 times per week or just using antifungal shampoo 2/3 times per week. The study will monitor how long it takes for symptoms to return, and assess quality of life, treatment satisfaction, and any side effects. The researchers believe that weekend-only use of steroid lotion may be effective in maintaining remission with fewer side effects.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 65 Yearss

Plain Language Summary

Simplified for easier understanding

Seborrheic dermatitis is a common skin condition that causes red, flaky, and sometimes itchy patches on the face and scalp. While treatments can bring it under control, flare-ups are common, and long-term use of steroid creams carries risks. This study is testing a smarter maintenance strategy: using a mild steroid lotion only on weekends, alongside a regular antifungal shampoo, to keep symptoms from returning. After a two-week treatment phase to bring symptoms under control, participants will be randomly assigned to either the weekend steroid plus shampoo approach or shampoo alone. The study will track how long it takes for symptoms to come back, how participants feel about their quality of life, and whether there are any side effects from the treatment. You may be eligible if you are aged 18 to 65, have been diagnosed with moderate to severe seborrheic dermatitis affecting your face or scalp, and have successfully completed the initial two-week treatment to achieve remission. This practical approach could offer people with this frustrating skin condition a simple, lower-risk way to stay symptom-free for longer.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Arm 1 – Intervention Group: Weekend Topical Corticosteroid Brief name: Weekend topical corticosteroid therapy (mometasone furoate 0.1%) Materials: Mometasone furoate 0.1% lotion (International Non

Arm 1 – Intervention Group: Weekend Topical Corticosteroid Brief name: Weekend topical corticosteroid therapy (mometasone furoate 0.1%) Materials: Mometasone furoate 0.1% lotion (International Non-proprietary Name). Participants will be provided with labeled tubes of the lotion and written instructions for application. Procedures/Activities: Participants first undergo a 2-week induction phase using mometasone furoate 0.1% lotion applied twice daily to affected facial and/or scalp area (1-1.5 Finger tip units for face, 3-4 Finger tip units for scalp), along with antifungal shampoo 2 to 3 times weekly ( every 2nd or 3rd day), to achieve remission. the induction phase can be extended from 2 weeks until there is remission. Upon achieving remission, participants enter the maintenance phase, during which they apply mometasone furoate 0.1% lotion twice per day on weekends ( Saturday and Sunday) to previously affected areas (1-1.5 FTUs for face, 3-4 FTUs for scalp) along with using antifungal shampoo 2 to 3 times weekly9 every 2nd or 3rd day). Provider: Self-administered by participants at home, following training and written instructions provided by dermatology clinic staff. Mode of Delivery: Self-application, individually, at home. Schedule and Duration: Maintenance treatment is delivered twice weekly for 12–24 weeks. Participants remain in the study for a minimum of 12 weeks, and up to 24 weeks if remission is sustained and follow-up monitoring is required. Follow-up visits are scheduled every 4 weeks at the dermatology clinic Each application is twice per day on weekends (Saturday and Sunday). Location: Participant’s home; monitored through outpatient dermatology clinics at scheduled follow-up visits (every 4 weeks). Adaptations: No personalization or titration; the same dose and frequency for all participants in the intervention group. Adherence and Fidelity: Assessed through participant self-reporting and tube weight checks at clinic visits. Clinicians will provide reminders and reinforce correct application at each follow-up.


Locations(1)

KPK, Pakistan

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