NCT03154528

Brief Summary

Androgenetic alopecia is a common form of diffuse hair loss in both men and women,It primarily affects the top and front of the scalp with different clinical presentations and there are numerous classification systems for grading purposes.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2019

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 13, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 16, 2017

Completed
1.9 years until next milestone

Study Start

First participant enrolled

March 30, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 21, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2019

Completed
Last Updated

January 15, 2019

Status Verified

January 1, 2019

Enrollment Period

5 months

First QC Date

May 13, 2017

Last Update Submit

January 11, 2019

Conditions

Alopecia, Androgenetic

Outcome Measures

Primary Outcomes (1)

  • Serum Vitamin D level

    Laboratory test

    1 year

Study Arms (2)

healthy control group

serum level of Vitamin D is going to be checked by ELISA in 30 healthy control volunteers

Diagnostic Test: serum vitamin D level by ELISA

case study group

serum level of Vitamin D is going to be checked by ELISA in 60 Androgenetic Alopecia patients.

Diagnostic Test: serum vitamin D level by ELISA

Interventions

serum vitamin D level by ELISADIAGNOSTIC_TEST

The study will include 60 patients with androgenetic alopecia (30 males \& 30 females) and 30 age and sex-matched healthy volunteers. Study subjects will be recruited from the Dermatology Outpatients' Clinic, Assiut University Hospitals, Assiut, Egypt. Informed consent will be obtained from all subjects

case study grouphealthy control group

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

The study will include 60 patients with androgenetic alopecia (30 males \& 30 females) and 30 age and sex-matched healthy volunteers. Study subjects will be recruited from the Dermatology Outpatients' Clinic, Assiut University Hospitals, Assiut, Egypt. Informed consent will be obtained from all subjects

You may qualify if:

  • The study will include 60 patients with androgenetic alopecia (30 males \& 30 females) and 30 age and sex-matched healthy volunteers.

You may not qualify if:

  • \- 1-Patients with a history of topical or systemic treatment within the last month.
  • Patients with a history of concomitant skin or systemic disease. 3- Pregnant or lactating women. 4- Smokers. 5- Patients receiving phototherapy within 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (14)

  • Varothai S, Bergfeld WF. Androgenetic alopecia: an evidence-based treatment update. Am J Clin Dermatol. 2014 Jul;15(3):217-30. doi: 10.1007/s40257-014-0077-5.

    PMID: 24848508RESULT

  • Gupta M, Mysore V. Classifications of Patterned Hair Loss: A Review. J Cutan Aesthet Surg. 2016 Jan-Mar;9(1):3-12. doi: 10.4103/0974-2077.178536.

    PMID: 27081243RESULT

  • Vujovic A, Del Marmol V. The female pattern hair loss: review of etiopathogenesis and diagnosis. Biomed Res Int. 2014;2014:767628. doi: 10.1155/2014/767628. Epub 2014 Apr 9.

    PMID: 24812631RESULT

  • Orme S, Cullen DR, Messenger AG. Diffuse female hair loss: are androgens necessary? Br J Dermatol. 1999 Sep;141(3):521-3. doi: 10.1046/j.1365-2133.1999.03049.x.

    PMID: 10583059RESULT

  • Kaliyadan F, Nambiar A, Vijayaraghavan S. Androgenetic alopecia: an update. Indian J Dermatol Venereol Leprol. 2013 Sep-Oct;79(5):613-25. doi: 10.4103/0378-6323.116730.

    PMID: 23974579RESULT

  • Errichetti E, Stinco G. Dermoscopy in General Dermatology: A Practical Overview. Dermatol Ther (Heidelb). 2016 Dec;6(4):471-507. doi: 10.1007/s13555-016-0141-6. Epub 2016 Sep 9.

    PMID: 27613297RESULT

  • Bikle DD. Vitamin D metabolism and function in the skin. Mol Cell Endocrinol. 2011 Dec 5;347(1-2):80-9. doi: 10.1016/j.mce.2011.05.017. Epub 2011 Jun 1.

    PMID: 21664236RESULT

  • Arnson Y, Amital H, Shoenfeld Y. Vitamin D and autoimmunity: new aetiological and therapeutic considerations. Ann Rheum Dis. 2007 Sep;66(9):1137-42. doi: 10.1136/ard.2007.069831. Epub 2007 Jun 8.

    PMID: 17557889RESULT

  • Malloy PJ, Feldman D. The role of vitamin D receptor mutations in the development of alopecia. Mol Cell Endocrinol. 2011 Dec 5;347(1-2):90-6. doi: 10.1016/j.mce.2011.05.045. Epub 2011 Jun 13.

    PMID: 21693169RESULT

  • Amor KT, Rashid RM, Mirmirani P. Does D matter? The role of vitamin D in hair disorders and hair follicle cycling. Dermatol Online J. 2010 Feb 15;16(2):3.

    PMID: 20178699RESULT

  • Rasheed H, Mahgoub D, Hegazy R, El-Komy M, Abdel Hay R, Hamid MA, Hamdy E. Serum ferritin and vitamin d in female hair loss: do they play a role? Skin Pharmacol Physiol. 2013;26(2):101-7. doi: 10.1159/000346698. Epub 2013 Feb 20.

    PMID: 23428658RESULT

  • Banihashemi M, Nahidi Y, Meibodi NT, Jarahi L, Dolatkhah M. Serum Vitamin D3 Level in Patients with Female Pattern Hair Loss. Int J Trichology. 2016 Jul-Sep;8(3):116-20. doi: 10.4103/0974-7753.188965.

    PMID: 27625563RESULT

  • Bakry OA, El Farargy SM, El Shafiee MK, Soliman A. Serum Vitamin D in patients with alopecia areata. Indian Dermatol Online J. 2016 Sep-Oct;7(5):371-377. doi: 10.4103/2229-5178.190504.

    PMID: 27730032RESULT

  • Bolland MJ, Ames RW, Grey AB, Horne AM, Mason BH, Gamble GD, Reid IR. Does degree of baldness influence vitamin D status? Med J Aust. 2008 Dec 1-15;189(11-12):674-5. doi: 10.5694/j.1326-5377.2008.tb02241.x.

    PMID: 19061473RESULT

Biospecimen

Retention: SAMPLES WITH DNA

blood sample

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

HypotrichosisHair DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Miral Taya, MD

    Assiut Uneversity

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eman Mohamed, MD

CONTACT

00201005298992e_riad@aun.edu.eg

Ayman Mohamed, MD

CONTACT

00201009948311aymanderma@yahoo.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

May 13, 2017

First Posted

May 16, 2017

Study Start

March 30, 2019

Primary Completion

August 21, 2019

Study Completion

December 12, 2019

Last Updated

January 15, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share