Androgenetic Alopecia and the JAK-STAT Pathway
Sponsor:
Cairo University
Collaborators:
Information provided by (Responsible Party):
Aya AlOrbani，Cairo University
| Tracking Information | |||
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| First Submitted Date ICMJE | October 1, 2018 | ||
| First Posted Date ICMJE | October 3, 2018 | ||
| Last Update Posted Date | October 3, 2018 | ||
| Actual Study Start Date ICMJE | October 15, 2018 | ||
| Estimated Primary Completion Date | February 1, 2019 (Final data collection date for primary outcome measure) | ||
| Current Primary Outcome Measures ICMJE |
Different in STAT3[ Time Frame: 6 months ] STAT3 levels in androgen-dependant areas compared to non-involved areas from occipital scalp(in an attempt to assess the possible role of the JAK-STAT pathway in androgenetic alopecia). |
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| Original Primary Outcome Measures ICMJE | Same as current | ||
| Current Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||
| Brief Title ICMJE | Androgenetic Alopecia and the JAK-STAT Pathway |
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| Official Title ICMJE | Assessment of the Role of the JAK-STAT Pathway in the Pathogenesis of Male Androgenetic Alopecia |
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| Brief Summary | It is a well known fact that the JAK-STAT pathway plays a pivotal role in the pathogenesis of alopecia areata. Both phosphorylated STAT 1 and 3 have been found to be upregulated in the disease (Xing et al., 2014). However, whether this pathway plays a role in other hair loss disorders remains unclear.(Sivan et al., 2015). Our study aims at assessing STAT3 levels in male patients with androgenetic alopecia. We hypothesize that STAT3 levels will be elevated (due to a previous study proving that JAK-STAT pathway is involved in non-immune mediated hair loss in mice (Sivan et al., 2015)). . |
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| Detailed Description | Background and rationale Androgenetic alopecia occurs in men and women,and is characterised by the loss of hair from the scalp in a defined pattern. Determining factors appear to be genetic predisposition coupled with the presence of sufficient circulating androgens(Ellis etal., 2002). The transformation of testosterone into dihydrotestosterone(DHT) by type 2 5-alpha reductase, which causes hair miniaturization,is universally accepted as the main player in the disease's pathogenesis (Whiting, 2001) Nonetheless,how DHT causes hair thinning is not well understood. New studies revealed that a lymphocytic microfolliculitis targeting the bulge epithelium along with deposits of epithelial basement membrane zone immunoreactants are frequent findings in androgenetic alopecia and could point toward an immunologically driven trigger (Magro et al., 2011). Tyrosine kinases (TKs) are enzymes involved in intracellular signaling that catalyze the phosphorylation of tyrosine residues on protein substrates. They are key components of signaling pathways that drive any array of cellular responses including proliferation, differentiation, migration and survival. Janus kinases (JAKs) are specific TKs (Paniagua et al., 2011). Signal transducer and activator of transcription (STAT) proteins are transcription factorsprimarily phosphorylated and activated by JAKs(Rawlings et al., 2004).The JAK-STAT pathway is utilized by cytokines including interleukins (ILs), interferons (IFNs), and other molecules to transmit signals from the cell membrane to the nucleus(Schwartzetal.,2016; O'Shea et al., 2015).Growing evidence suggests that JAK inhibitors are efficacious in atopic dermatitis, alopecia areata, psoriasis and vitiligo(Damsky and King, 2017). It is a well known fact that the JAK-STAT pathway plays a pivotal role in the pathogenesis of alopecia areata. Both phosphorylated STAT 1 and 3 have been found to be upregulated in the disease (Xing et al., 2014). However, whether this pathway plays a role in other hair loss disorders remains unclear.(Sivan et al., 2015). A study showedthat topical treatment of mouse and human skin with small molecule inhibitors of the JAK-STATpathway resulted in rapid onset of anagen and subsequent hair growth. It was shown that JAK inhibition regulates the activation of key hair follicle populations such as the hair germ. These findings indicate that the JAK-STAT pathway may be involved, not only in immune-mediated hair loss (alopecia areata), but also in the normal hair cycle(Sivan et al., 2015). Our current study aims at assessing STAT3 levels in patients with androgenetic alopecia, in an attempt to detect a possible role of the JAK-STAT pathway in the pathogenesis of the disease. Objective: Our objective is to compare tissue levels of STAT3 in androgen-dependant areas in male androgenetic alopecia patients with their level in non-involved, non-androgen dependant areas (occipital scalp) in the same subjects. Population of study & disease condition (e.g women with hepatitis, ............) Males with androgenetic alopecia Background and demographic characteristics( e.g age,.......) - Age above 18 years. - Males Interventions : Each subject will be subjected to: - Informed consent. - Detailed history and clinical evaluation to determine severity of disease. - Punch biopsies (1mm) of affected area of scalp (androgen dependent area) from 25 patients with androgenetic alopecia. - Punch biopsies(1mm) of normal area of scalp from occipital scalp (non-androgen dependent area) from the same 25 patients - Quantification of STAT3 by polymerase chain reaction (PCR). Sample size (number of participants included) - 25 participants (That will serve as both patients and controls) - Sample size calculation was done using G ⃰ Power 3.1.9.2. Possible. Risk Bleeding, secondary infection, scarring. | ||
| Study Type ICMJE | Observational | ||
| Study Phase | |||
| Study Design ICMJE | Allocation: Intervention Model: Intervention Model Description: Masking: Observational Masking Description: Primary Purpose: |
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| Intervention ICMJE |
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| Recruitment Information | |||
| Recruitment Status ICMJE | Not yet recruiting | ||
| Estimated Enrollment ICMJE |
25 | ||
| Original Estimated Enrollment ICMJE | Same as current | ||
| Estimated Study Completion Date | April 1, 2019 | ||
| Estimated Primary Completion Date | February 1, 2019 (Final data collection date for primary outcome measure) | ||
| Eligibility Criteria ICMJE | Inclusion Criteria: - Males with androgenetic alopecia not receiving topical treatment nor systemic treatment for hair loss for at least 6 month prior to the study Exclusion Criteria: - Patients with localized or generalized hair loss due to causes other than androgenetic alopecia. | ||
| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||
| Accepts Healthy Volunteers | No | ||
| Listed Location Countries ICMJE | Egypt | ||
| Removed Location Countries | |||
| Administrative Information | Has Data Monitoring Committee | No | |
| U.S. FDA-regulated Product |
Studies a U.S. FDA-regulated Drug Product: No Studies a U.S. FDA-regulated Device Product: No |
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| IPD Sharing Statement |
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| Responsible Party | Aya AlOrbani，Cairo University | ||
| Study Sponsor ICMJE | Cairo University | ||
| Collaborators ICMJE | |||
| Investigators ICMJE |
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| PRS Account | Cairo University | ||
| Verification Date | October 2018 | ||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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