Telogen Effluvium Clinical Trial
Official title:
Demonstration of the Presence of a Carbonyl Stress in the Hair Follicles of Postpartum Women
Verified date | May 2020 |
Source | Pierre Fabre Dermo Cosmetique |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
In this study, the investigator will try to highlight the presence of carbonyl compounds in the hair follicles of postpartum women by comparing these compounds before and after delivery.
Status | Completed |
Enrollment | 20 |
Est. completion date | December 16, 2019 |
Est. primary completion date | September 6, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility |
Inclusion Criteria: Criteria related to the Population: - Pregnant woman (= 33 weeks of amenorrhea) - Woman aged between 18 and 40 years (included) - Phototype I to IV included according to Fitzpatrick's classification - Affiliation to a French social security scheme or benefiting from such a scheme - Signed informed consent form Exclusion Criteria: Criteria related to the Population: - High risk or pathological pregnancy, according to the opinion of the investigator - Deprivation of liberty by administrative or judicial decision or subject under guardianship - Impossibility, according to the investigator, to comply with the requirements of the protocol - Linguistic or psychic incapacity to sign informed consent - Concomitant participation in a clinical study that may interfere with the results of the study, according to the opinion of the investigator (excluding observational studies) Criteria related to Pathology : - Alopecia causing hair loss on the upper part of the scalp - Dermatological pathology or evolving cutaneous lesion in the scalp - Known history of hepatitis B and C, HIV - Past or present neoplastic condition - Acute evolving pathology - Gestational diabetes treated with insulin Criteria related to Treatments: - Treatment of general thyroid disorders initiated or modified for less than 3 months prior to inclusion (or change of specialty for less than 3 months) - Systemic treatment affecting hair growth taken for at least 4 weeks during the 3 months prior to inclusion - Systemic treatment: nonsteroidal anti-inflammatory drug, corticosteroid, antibiotic, antihistamine taken for 5 consecutive days within 2 weeks prior to inclusion or that may interfere with the results of the study according to the investigator, - Dermal use, for at least 4 weeks, of Minoxidil, Aminexil within 3 months prior to inclusion - Dermal use in the 4 weeks prior to inclusion, of any product that may be active on the hair follicle and scalp or may affect the dosage of carbonyl compounds (including hair dyes) - Last shampoo less than 2 days before the inclusion and application of styling / care products (gel, lacquer, wax, conditioner ...) or water between the last shampoo and the inclusion |
Country | Name | City | State |
---|---|---|---|
France | Hôpital Purpan | Toulouse |
Lead Sponsor | Collaborator |
---|---|
Pierre Fabre Dermo Cosmetique |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change of biological evaluation | Evaluation of the quantity of carbonyl compounds measured in the hair follicles taken before and after delivery. | 1st sample: inclusion visit (up to 8 weeks before delivery)- 2nd sample: end of study visit (10 to 16 weeks after delivery) | |
Secondary | Safety evaluation | Adverse events evaluation for all subjects, all along the study | From inclusion to end of study |
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