Alopecia, AndrogeneticNCT03154528
Role of Vitamin D in Androgenetic Alopecia
An observational study of Alopecia, Androgenetic, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Alopecia, Androgenetic
- What is being tested?
- serum vitamin D level by ELISA
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 30 Mar 2019to 12 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
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
Who may be able to join
- The study will include 60 patients with androgenetic alopecia (30 males \& 30 females) and 30 age and sex-matched healthy volunteers.
Who cannot join
- 1-Patients with a history of topical or systemic treatment within the last month.
- 2-Patients with a history of concomitant skin or systemic disease. 3- Pregnant or lactating women. 4- Smokers. 5- Patients receiving phototherapy within 6 months
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the detailed description
These systems vary from the simple systems based on recession of the hairline to more advanced multifactorial systems based on morphological and dynamic parameters that affect the scalp and hair. Most of these systems have certain limitations. Currently, the most commonly used are Hamilton- Norwood classification system for males where there are two areas of hair loss that gradually enlarge to produce recession at the temples and thinning in the crown. These regions coalesce until the entire front, top and crown (vertex) of the scalp are bald(2 major pattern,7 grades) and the Ludwig system for females which classify the Female Pattern Hair Loss into three grades depending on the reduction in hair density over the crown and frontal scalp with retention of the frontal hairline.
Etiopathogenesis of Androgenetic Alopecia has not yet been fully elucidated. Genetic factors, hair follicle cycle abnormalities, aging process and androgen dependent process including end organ sensitivity have been all incriminated as etiological factors .
Dermoscopy has emerged as an useful tool in the diagnosis of hair loss disorder including Androgenetic Alopecia. Important features of Androgenetic Alopecia on Dermoscopy include hair shaft thickness heterogeneity, yellow dots (irregularly distributed and with a remarkable variability in size and shape), perifollicular discolouration (the peripilar sign), an increased proportion of thin and vellus hairs (>10 % of the hairs) and a large number of follicular units with only one emerging hair shaft. Thin wavy hair and honeycomb hyperpigmentation often coexist as additional, nonspecific features Vitamin D is a secosteroid hormone that plays an important role in calcium homeostasis and bone health. It has three sources: endogenous synthesis in the skin, which is induced by Ultraviolet B radiation; dietary intake; and supplementation .
Basically, Vitamin D is a modulator of both innate and adaptive immune systems through its various effects on T and B lymphocytes, dendritic cells and macrophages. There is a well-established causal connection between vitamin D deficiency and some autoimmune diseases , and possible association with some hair disorders, as it has been demonstrated that vitamin D receptors are strongly expressed in hair follicles and keratinocytes. Such an expression was found to be necessary for maintenance of the normal hair cycle. Also, it has also been shown that lack of vitamin D receptors reduces epidermal differentiation and hair follicle growth, and that an optimum concentration of Vitamin D3 is essential to delay aging and hair loss.
Several studies were done to evaluate the role of vitamin D in different hair disorders with contrasting results. Some studies revealed low serum levels of Vitamin D in women with chronic telogen effluvium,Female Pattern Hair Loss and Alopecia Areata.While, two studies showed no correlation between the extent and severity of male androgenetic alopecia with serum Vitamin D3 level.
Based on the above contrasting reports, we sought to evaluate the levels of Vitamin D in patients with androgenetic alopecia in order to establish its possible role in the etiopathogenesis and hence in the treatment of such a common and chronic hair disorder
- Conditions
- Alopecia, Androgenetic
- Being tested
- serum vitamin D level by ELISA
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| healthy control group | serum level of Vitamin D is going to be checked by ELISA in 30 healthy control volunteers Receives: 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. Receives: Diagnostic Test: serum vitamin D level by ELISA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Vitamin D level
Laboratory test
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2017
- Study start30 Mar 2019 (estimated)
- Primary completion21 Aug 2019 (estimated)
- Study completion12 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Alopecia, AndrogeneticStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miral Hassan, Assiut University
- Investigators
- Miral Taya, MD, Principal investigator, Assiut Uneversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03154528
- Sponsor's protocol ID
- MAGA2017
- Status last verified
- Jan 2019
- First submitted
- 13 May 2017
- Last updated
- 15 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24848508Gupta 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.
PubMed 27081243Vujovic 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.
PubMed 24812631Orme 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.
PubMed 10583059Kaliyadan 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.
PubMed 23974579Errichetti 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.
PubMed 27613297Bikle 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.
PubMed 21664236Arnson 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.
PubMed 17557889Malloy 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.
PubMed 21693169Amor 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.
PubMed 20178699Rasheed 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.
PubMed 23428658Banihashemi 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.
PubMed 27625563Bakry 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.
PubMed 27730032Bolland 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.
PubMed 19061473
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Vitamin D in Androgenetic Alopecia
- ClinicalTrials.gov ID
- NCT03154528
- Acronym / sponsor ID
- MAGA2017
- Conditions
- Alopecia, Androgenetic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 30 Mar 2019 (estimated)
- Primary completion
- 21 Aug 2019 (estimated)
- Study completion
- 12 Dec 2019 (estimated)
- First posted
- 16 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
These systems vary from the simple systems based on recession of the hairline to more advanced multifactorial systems based on morphological and dynamic parameters that affect the scalp and hair. Most of these systems have certain limitations. Currently, the most commonly used are Hamilton- Norwood classification system for males where there are two areas of hair loss that gradually enlarge to produce recession at the temples and thinning in the crown. These regions coalesce until the entire front, top and crown (vertex) of the scalp are bald(2 major pattern,7 grades) and the Ludwig system for females which classify the Female Pattern Hair Loss into three grades depending on the reduction in hair density over the crown and frontal scalp with retention of the frontal hairline.
Etiopathogenesis of Androgenetic Alopecia has not yet been fully elucidated. Genetic factors, hair follicle cycle abnormalities, aging process and androgen dependent process including end organ sensitivity have been all incriminated as etiological factors .
Dermoscopy has emerged as an useful tool in the diagnosis of hair loss disorder including Androgenetic Alopecia. Important features of Androgenetic Alopecia on Dermoscopy include hair shaft thickness heterogeneity, yellow dots (irregularly distributed and with a remarkable variability in size and shape), perifollicular discolouration (the peripilar sign), an increased proportion of thin and vellus hairs (>10 % of the hairs) and a large number of follicular units with only one emerging hair shaft. Thin wavy hair and honeycomb hyperpigmentation often coexist as additional, nonspecific features Vitamin D is a secosteroid hormone that plays an important role in calcium homeostasis and bone health. It has three sources: endogenous synthesis in the skin, which is induced by Ultraviolet B radiation; dietary intake; and supplementation .
Basically, Vitamin D is a modulator of both innate and adaptive immune systems through its various effects on T and B lymphocytes, dendritic cells and macrophages. There is a well-established causal connection between vitamin D deficiency and some autoimmune diseases , and possible association with some hair disorders, as it has been demonstrated that vitamin D receptors are strongly expressed in hair follicles and keratinocytes. Such an expression was found to be necessary for maintenance of the normal hair cycle. Also, it has also been shown that lack of vitamin D receptors reduces epidermal differentiation and hair follicle growth, and that an optimum concentration of Vitamin D3 is essential to delay aging and hair loss.
Several studies were done to evaluate the role of vitamin D in different hair disorders with contrasting results. Some studies revealed low serum levels of Vitamin D in women with chronic telogen effluvium,Female Pattern Hair Loss and Alopecia Areata.While, two studies showed no correlation between the extent and severity of male androgenetic alopecia with serum Vitamin D3 level.
Based on the above contrasting reports, we sought to evaluate the levels of Vitamin D in patients with androgenetic alopecia in order to establish its possible role in the etiopathogenesis and hence in the treatment of such a common and chronic hair disorder
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| healthy control group | – | Diagnostic Test: serum vitamin D level by ELISAserum level of Vitamin D is going to be checked by ELISA in 30 healthy control volunteers |
| case study group | – | Diagnostic Test: serum vitamin D level by ELISAserum level of Vitamin D is going to be checked by ELISA in 60 Androgenetic Alopecia patients. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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
Key inclusion criteria (1 listed)
- The study will include 60 patients with androgenetic alopecia (30 males \& 30 females) and 30 age and sex-matched healthy volunteers.
Key exclusion criteria (2 listed)
- 1-Patients with a history of topical or systemic treatment within the last month.
- 2-Patients with a history of concomitant skin or systemic disease. 3- Pregnant or lactating women. 4- Smokers. 5- Patients receiving phototherapy within 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| serum vitamin D level by ELISAThe 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 | Diagnostic test | case study group, healthy control group |
Primary outcome
Serum Vitamin D level
Time frame: 1 year
Laboratory test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2019.
- Results publication: PubMed 24848508Varothai 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.
- Results publication: PubMed 27081243Gupta 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.
- Results publication: PubMed 24812631Vujovic 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.
- Results publication: PubMed 10583059Orme 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.
- Results publication: PubMed 23974579Kaliyadan 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.
- Results publication: PubMed 27613297Errichetti 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.
- Results publication: PubMed 21664236Bikle 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.
- Results publication: PubMed 17557889Arnson 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.
- Results publication: PubMed 21693169Malloy 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.
- Results publication: PubMed 20178699Amor 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.
- Results publication: PubMed 23428658Rasheed 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.
- Results publication: PubMed 27625563Banihashemi 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.
- Individual participant dataSharing planned: No
Related trials for Alopecia, Androgenetic
Not yet recruitingPhase 2
Phase 2 Efficacy and Safety of PP405 in Adult Females With Androgenetic Alopecia
Androgenetic Alopecia
Not yet recruitingPhase 3
Phase 3 Study to Evaluate the Efficacy and Safety of Oral Minoxidil (N1087) in Men With Androgenetic Alopecia.
Androgenetic Alopecia, Androgenetic Alopecia (AGA)
Not yet recruiting
Study to Evaluate Xtressé Gummy Supplement in Women With Thinning Hair
Androgenetic Alopecia
Not yet recruitingEarly Phase 1
Evaluating the Efficacy of Platelet-rich Plasma Therapy in the Treatment of Androgenic Alopecia
Androgenic Alopecia
Not yet recruitingPhase 3
Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of N1087 in Participants With Female Pattern Hair Loss (MINORA-WOMEN)
Female Pattern Hair Loss, Female Pattern Hair Loss, Androgenic Alopecia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miral Taya, MD principal investigator
Assiut Uneversity
Questions about this trial
What is this clinical trial studying?
An observational study of Alopecia, Androgenetic, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eman Mohamed, MD (00201005298992, e_riad@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Vitamin D level (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03154528, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2019.