deltatrials
Completed PHASE4 INTERVENTIONAL 3-arm NCT01167946

Safety and Efficacy of Oral Mega Pulse Methylprednisolone in Severe Therapy Resistant Alopecia Areata

Sponsor: King Saud University

Updated 5 times since 2017 Last updated: Jul 21, 2010 Started: Jan 31, 2003 Primary completion: Dec 31, 2009 Completion: Jul 31, 2010
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE4 clinical study on Alopecia Totalis and Alopecia Universalis, this trial is completed. The trial is conducted by King Saud University and has accumulated 5 data snapshots since 2003. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Study Description(click to expand)

This will be a single-center, prospective, randomized study conducted in King Khalid University Hospital. Patients diagnosed with either Alopecia universalis, Alopecia totalis or Ophiasic alopecia will be included in the study. Patients with contraindications such as diabetes mellitus, peptic ulcer, hypertension, infection, psychosis, heart or kidney disease, endocrine disorders (apart from a subclinical hypothyroidism and autoimmune thyroiditis) will be excluded. Children less than 5 years of age and those who received systemic or topical treatment within the last 4 weeks before enrollment will be also excluded. Those of child bearing potential had to have a negative urine pregnancy test result at baseline visit and should practice a reliable method of contraception throughout the study. 42 eligible patients will be randomly assigned to one of 3 treatment groups. Enrolled patients must provide written informed consent. Institutional review board approval will be obtained.

This will be a single-center, prospective, randomized study conducted in King Khalid University Hospital. Patients diagnosed with either Alopecia universalis, Alopecia totalis or Ophiasic alopecia will be included in the study. Patients with contraindications such as diabetes mellitus, peptic ulcer, hypertension, infection, psychosis, heart or kidney disease, endocrine disorders (apart from a subclinical hypothyroidism and autoimmune thyroiditis) will be excluded. Children less than 5 years of age and those who received systemic or topical treatment within the last 4 weeks before enrollment will be also excluded. Those of child bearing potential had to have a negative urine pregnancy test result at baseline visit and should practice a reliable method of contraception throughout the study. 42 eligible patients will be randomly assigned to one of 3 treatment groups. Enrolled patients must provide written informed consent. Institutional review board approval will be obtained.

Status Flow

~Jan 2017 – ~Jan 2021 · 48 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 19 months · monthly snapshotCompleted~Jan 2026 – present · 3 months · monthly snapshotCompleted

Change History

5 versions recorded
  1. Jan 2026 — Present [monthly]

    Completed PHASE4

  2. Sep 2024 — Present [monthly]

    Completed PHASE4

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE4

  4. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE4

  5. Jan 2017 — Jan 2021 [monthly]

    Completed PHASE4

    First recorded

Jan 2003

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • King Saud University
  • Saudi Society of Dermatology and Dermatologic surgery
Data source: King Saud University

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations