Telogen Effluvium Clinical Trial
Official title:
Randomized, Comparative Study to Assess the Effects of Cosmetic Lotion on Telogen Effluvium in Women Compared to a Control Group
Verified date | November 2020 |
Source | Pierre Fabre Dermo Cosmetique |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Telogen effluvium (TE) is one of the most common causes of non-scarring diffuse hair loss, defined as global diminution of hair with no formation of areas completely bald. Premature termination of anagen into catagen and telogen hair follicle is the main mechanism observed in TE. It results in increased, synchronized telogen shedding leading to a decrease in global hair density. Acute telogen effluvium (ATE) has an abrupt onset and generalized scalp hair loss occurring 2-3 months after a triggering event, which could be unidentifiable in up to 33% cases. The degree of effluvium depends on the severity, duration of exposure and the type of agent, that can be: emotional stress, hormonal changes in the postpartum period, high fever, surgery, surgical/accidental trauma, severe haemorrhage, chronic systemic illness, or immense psychological stress, changes in medication or crash-diets. A summer effect possibly ultraviolet (UV) light induced, manifesting itself in autumn can cause ATE. The incidence of TE is not known, although it is likely that most women will experience at least 1 episode of TE during a lifetime. ATE can be diagnosed based on relevant medical and personal history and examination subjective complaints, clinical and physical exams or relevant investigations (hair pull test, phototrichogram, blood test…). ATE generates a lot of anxiety in the patient: significant impact on quality of life, self-esteem impairment, and stress increase. Thus, stress may act as a primary inducer; an aggravating factor or be a response to hair loss. ATE usually remits within few months (3-4 to 6 months) in 95% of cases if the trigger is removed or treated. Complete recovery may take until 1 year. A resolving TE is characterized by the absence of hair shedding, a negative hair pull test and synchronized hair growth. In this study, our aim is to assess the effects of the RV3466F lotion on hair growth, compared to a control group, with clinical and biometrological non- invasive methods on an adult female population with telogen effluvium.
Status | Completed |
Enrollment | 100 |
Est. completion date | June 22, 2017 |
Est. primary completion date | June 22, 2017 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 50 Years |
Eligibility | Selection criteria : Criteria related to the population: - Woman aged between 18 and 50 years old included - Phototype I to IV included, according to Fitzpatrick classification - Subject having signed written informed consent for the participation in the study - Subject affiliated to a social security system or health insurance, or is a beneficiary of either (if required by national regulation) - Subject whose last shampoo has been done at least 2 days before the selection visit - Use of a contraceptive method assessed as efficient by an investigator (including tubal ligation), started since at least 3 months before the selection visit, continued during the study and until after 1 month after the study end - Subject having hair length of at least 5 cm Criteria related to diseases and hair loss disorder: - Subject having effluvium telogen Non selection criteria : Criteria related to the population: - Pregnant or breastfeeding women or planning to being pregnant during the study - Perimenopausal symptoms (irregular menstruations, premenstrual syndrome …) or menopausal symptoms (climacteric troubles: hot flush, headaches, tiredness, insomnia, irritability …) - Menopause (absence of menstruations since at least 1 year) or a bilateral ovariectomy - Subject having frizzy hair - Subject who has forfeited her freedom by administrative or legal award or is under guardianship - Subject who, according to the judgement of the investigator, is unlikely to be compliant during the study - Subject unable to understand the information given (for linguistic or psychiatric reasons) and to give her consent in writing to participate - Subject who is currently participating in any another clinical trial - Subject who has participated in another clinical trial with hair product or treatment (local on the scalp and/or systemic) within the last 12 weeks before the selection visit Criteria related to diseases and hair loss disorders: - Subject who has any other hair disorder or hair disease (Ludwig II, III, AA, scarring alopecia …) Criteria related to the population: - Pregnant or breastfeeding women or planning to being pregnant during the study - Perimenopausal symptoms (irregular menstruations, premenstrual syndrome …) or menopausal symptoms (climacteric troubles: hot flush, headaches, tiredness, insomnia, irritability …) - Menopause (absence of menstruations since at least 1 year) or a bilateral ovariectomy - Subject having frizzy hair - Subject who has forfeited her freedom by administrative or legal award or is under guardianship - Subject who, according to the judgement of the investigator, is unlikely to be compliant during the study - Subject unable to understand the information given (for linguistic or psychiatric reasons) and to give her consent in writing to participate - Subject who is currently participating in any another clinical trial - Subject who has participated in another clinical trial with hair product or treatment (local on the scalp and/or systemic) within the last 12 weeks before the selection visit Criteria related to diseases and hair loss disorders: - Subject who has any other hair disorder or hair disease (Ludwig II, III, AA, scarring alopecia …) - History or clinical signs of hyperandrogenemia (menstrual cycle >35 days and hirsutism and signs of acne) - Inflammatory skin disease or progressive skin lesion on the scalp (psoriasis, seborrheic dermatitis, severe erythema, severe excoriation, severe sunburn, etc.). - Neoplastic disease at any time - History of hypersensitivity or intolerance to any of the following components applied by topical route: ethyl alcohol, components of the used hair dye, components of the RV3466F lotion - Thyroid disorders stabilised for less than 3 months Criteria related to treatments and products: - Systemic treatment affecting the hair growth taken for more than 4 weeks during the last 12 weeks before the selection visit: - Finasteride - Dutasteride - Retinoids - Anti-mitotic, cytotoxic drugs other than antineoplastic - Spironolactone, flutamide, and all androgens - Anti-epileptic agents, interferon alpha - Minoxidil, Aminexil applied on the scalp within the last 24 weeks before the selection visit - Systemic or local anti hair loss treatment or product, taken or applied (cosmetic solution or capsules with vitamin B, zinc, caffeine…) within the last 4 weeks before the selection visit. - Drugs for thyroid disorders, if non stabilized for at least 3 months, - Iron supplement if not started for at least 3 months - Any hair care or styling method within the last week before the selection visit (e.g. dyeing, bleaching, perm, straightening, …) - Any hair care product applied on the scalp between the last shampoo and the selection visit (e.g. gel, hairspray, wax, foam, …) or water or brushing. - Any food supplements for hair growth taken for more than 4 weeks during the 12 weeks before the selection visit - Radiotherapy, chemotherapy at any time - Scalp surgery (hair transplants, laser) within the 12 months before the selection visit Inclusion criteria : - Criteria related to hair loss disorder: - Subject having a proportion of hair in telogen phase superior to 15% (determined by phototrichogram at inclusion) on the centroparietal area of the scalp - Subject having a total hair density superior or equal to = 220 hairs/ cm2 (determined by phototrichogram at inclusion) on the centroparietal area of the scalp Non inclusion criteria : - Criteria related to treatments and products: - Any hair care product applied on the scalp between the selection visit and the inclusion visit (e.g. gel, hairspray, wax, foam, …) or water or brushing. - Reaction to the used hair dye during the inclusion visit |
Country | Name | City | State |
---|---|---|---|
France | Centre de santé SABOURAUD C.E.P.C | Paris | |
France | INTERTEK | Paris |
Lead Sponsor | Collaborator |
---|---|
Pierre Fabre Dermo Cosmetique |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | anagen to telogen ratio | From phototrichogram on the centroparietal area of the scalp | Change from baseline to 16 weeks after application, for each group | |
Secondary | anagen to telogen ratio | From phototrichogram on the centroparietal area of the scalp | 1 week, 4 weeks and 8 weeks after application, for each group | |
Secondary | Density of telogen hair (number of hair in telogen phase/cm²) | From phototrichogram on the centroparietal area of the scalp | 1 week, 4 weeks, 8 weeks and 16 weeks after application, for each group | |
Secondary | Density of anagen hair (number of hair in anagen phase/cm²) | From phototrichogram on the centroparietal area of the scalp | 1 week, 4 weeks, 8 weeks and 16 weeks after application, for each group | |
Secondary | Total hair density (number of total hairs/cm²) | From phototrichogram on the centroparietal area of the scalp | 1 week; 4 weeks, 8 weeks and 16 weeks after application, for each group | |
Secondary | Hair thickness | From phototrichogram on the centroparietal area of the scalp | 1 week, 4 weeks, 8 weeks and 16 weeks after application, for each group | |
Secondary | Cumulative hair thickness | From phototrichogram on the centroparietal area of the scalp | 1 week, 4 weeks, 8weeks and 16 weeks after application, for each group | |
Secondary | Percentage of hairs pulled out | From the hair pull test on right and left bitemporal areas, frontal and occipital areas. | 1 week, 4 weeks, 8 weeks 12 weeks and 16 weeks after application, for each group | |
Secondary | Total number of hairs shed | From the 60-s hair count test on the whole scalp | 4 weeks, 8 weeks 12 weeks and 16 weeks after application, for each group | |
Secondary | Efficacy and cosmetic acceptability questionnaire | Self-assessment questionnaire filled by the subjects. Ad-hoc questionnaires including numerical scale from 0-10 where higher scores mean a better outcome (improvement) | 1 week; 4 weeks, 8 weeks and 16 weeks after application, for each group | |
Secondary | Density assessment | From globalphotographs of the centroparietal area with a stereotactic device, blinded and assessed by experts using a 7-points scale: Important aggravation (less dense)=-3; Moderate aggravation=-2; Mild aggravation=-1; Unchanged=0; Mild improvement=1; Moderate improvement=2; Important improvement (denser)=3 | 1 week and 16 weeks after application, for each group |
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