Clinical Study for the Evaluation of the Depigmenting Activity of a Cosmetic Product on Spotted Hand Skin
NCT ID: NCT02204436
Last Updated: 2014-07-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
22 participants
INTERVENTIONAL
2013-11-30
2014-01-31
Brief Summary
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Female healthy volunteers aged 45-65 years old, presenting senile lentigo on the hands, were included in the study.
It was also aim of this study to evaluate treatment efficacy and cosmetic acceptability by the volunteers and tolerance both by investigator and volunteers.
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Detailed Description
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* Image analysis with UV flash (Wood's light)
* Photographic recovery
* Skin spots image analysis
* Skin colour evaluation
* Spectrophotometry (skin brightness)
* Optical colorimetry (spots colour)
At the end of the study (T8), each volunteer filled a questionnaire regarding:
* the efficacy of the study product (skin brightness and hydration, spots dimensions and colour intensity - score: very marked; marked; medium; light; absent)
* the cosmetic acceptability of the study product: colour and perfume before and after application, consistency, spreadability, absorption, effect on the skin, greasiness and presence of product residues (score: negative; medium; good; excellent) the product tolerance (score: bad; poor; medium; good; excellent).
At the end of the study the investigator assessed the treatment tolerance considering the possible appearance of related adverse events as bad, poor, medium, good, excellent.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Emulsion and gel
A fixed similar quantity of both emulsion and gel were applied consequentially on the hand twice a day, in the morning and in the evening (preferentially always at the same hour), with a mild massage, until complete absorption, for 8 weeks.
Emulsion and gel
A fixed similar quantity of both emulsion and gel were applied consequentially on the hand twice a day, in the morning and in the evening (preferentially always at the same hour), with a mild massage, until complete absorption, for 8 weeks.
Interventions
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Emulsion and gel
A fixed similar quantity of both emulsion and gel were applied consequentially on the hand twice a day, in the morning and in the evening (preferentially always at the same hour), with a mild massage, until complete absorption, for 8 weeks.
Eligibility Criteria
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Inclusion Criteria
* age 45-65 years
* presence of moderate senile lentigo on the back of the hands
* accepting to not receive any drugs/cosmetic/chemical or physical treatment (peeling, intradermal implants etc.) able to change the skin characteristics during the entire duration of the study
* accepting to use the study product according to the instruction received by the investigator
* accepting not to expose to strong UV irradiation (UV session, or sun bathes) during the entire duration of the study
* subject agreeing not to use anti-spots products/treatments during the month preceding the test
* accepting to sign the Informed Consent Form
Exclusion Criteria
* lactation
* sensitivity to the test product or its ingredients
* subjects whose insufficient adhesion to the study protocol is foreseeable
* participation in a similar study actually or during the previous 3 months
* dermatological disease (dermatitis; presence of cutaneous disease on the tested area, as lesions, scars, malformations)
* clinical and significant skin condition on the test area (e.g. active eczema, dermatitis, psoriasis. etc.)
* diabetes
* endocrine disease
* hepatic disorder
* renal disorder
* cardiac disorder
* pulmonary disease
* cancer
* neurological or psychological disease
* inflammatory/immunosuppressive disease
* drug allergy
* systemic corticosteroids
* aspirin or non-steroid anti-inflammatory drugs (FANS)
* anti-histaminic, narcotic, antidepressant, immunosuppressive drugs (with except of contraceptive or hormonal treatment starting from at least 1 year)
* assumption of drugs able to influence the test results in the investigator opinion
45 Years
65 Years
FEMALE
Yes
Sponsors
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Derming SRL
OTHER
Responsible Party
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Principal Investigators
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Adele Sparavigna, Doctor
Role: PRINCIPAL_INVESTIGATOR
Derming SRL
Locations
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DermIng SRL
Monza, Monza, Italy
Countries
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References
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Asawanonda P, Taylor CR. Wood's light in dermatology. Int J Dermatol. 1999 Nov;38(11):801-7. doi: 10.1046/j.1365-4362.1999.00794.x. No abstract available.
Asserin J., Heusèle C., André P. , Preece S., Schnebert S. , Taieb A. Comparison of two techniques used in the evaluation of the depigmentation effect of cosmetic products on brown spots, 2004
Claridge E, Cotton S, Hall P, Moncrieff M. From colour to tissue histology: Physics-based interpretation of images of pigmented skin lesions. Med Image Anal. 2003 Dec;7(4):489-502. doi: 10.1016/s1361-8415(03)00033-1.
Claridge E, Preece SJ. An inverse method for the recovery of tissue parameters from colour images. Inf Process Med Imaging. 2003 Jul;18:306-17. doi: 10.1007/978-3-540-45087-0_26.
Curry AS, Gettings SD, McEwen GN CTFA safety testing guidelines. The Cosmetic, Toiletry and Fragrance Association, Washington, 1991
Fernay, Voltaire The World Medical Association (1989) "World Medical Association Declaration of Helsinki", Hong-Kong
Fullerton A, Fischer T, Lahti A, Wilhelm KP, Takiwaki H, Serup J. Guidelines for measurement of skin colour and erythema. A report from the Standardization Group of the European Society of Contact Dermatitis. Contact Dermatitis. 1996 Jul;35(1):1-10. doi: 10.1111/j.1600-0536.1996.tb02258.x.
Gilchrest BA, Fitzpatrick TB, Anderson RR, Parrish JA. Localization of malanin pigmentation in the skin with Wood's lamp. Br J Dermatol. 1977 Mar;96(3):245-8. doi: 10.1111/j.1365-2133.1977.tb06132.x.
Gupta LK, Singhi MK. Wood's lamp. Indian J Dermatol Venereol Leprol. 2004 Mar-Apr;70(2):131-5. No abstract available.
Matts Paul J., Carey Jeremy, Cotton Symon D. Chromophore Mapping: a New Technique to Characterize Aging Human Skin, In Vivo. American Academy of Dermatology 2005
Matts PJ, Dykes PJ, Marks R. The distribution of melanin in skin determined in vivo. Br J Dermatol. 2007 Apr;156(4):620-8. doi: 10.1111/j.1365-2133.2006.07706.x.
Moncrieff M, Cotton S, Claridge E, Hall P. Spectrophotometric intracutaneous analysis: a new technique for imaging pigmented skin lesions. Br J Dermatol. 2002 Mar;146(3):448-57. doi: 10.1046/j.1365-2133.2002.04569.x.
Rieger M.M., Battista G.W. Some experiences in the safety testing of cosmetics J. Soc. Cosmet. Chem. 15:161 -172 , 1964
Rigano L. "Evaluation of the efficacy of a whitening product" ISPE Institute of Skin and Product Evaluation - March 15th 2007
Sachs L. Applied statistics: a handbook of techniques Heidelberg: Springer, 1981:536-539
Taelman M-C, Dederen J. C. Relative performance testing of formulations: emulsifiers Cosmetics &Toiletries magazine August 2000; 115: 37-42
Takiwaki H. Measurement of skin color: practical application and theoretical considerations. J Med Invest. 1998 Feb;44(3-4):121-6.
Zonios G, Bykowski J, Kollias N. Skin melanin, hemoglobin, and light scattering properties can be quantitatively assessed in vivo using diffuse reflectance spectroscopy. J Invest Dermatol. 2001 Dec;117(6):1452-7. doi: 10.1046/j.0022-202x.2001.01577.x.
Related Links
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Sponsor
Other Identifiers
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E3013
Identifier Type: -
Identifier Source: org_study_id
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