Clinical Study for the Evaluation of the Depigmenting Activity of a Cosmetic Product on Spotted Hand Skin

NCT02204436 | Completed Phase 3 DMC

• 1 other identifier: E3013
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

Aim of the study was to evaluate by instrumental measurements the depigmenting activity of a cosmetic treatment for spotted hand skin; in particular it was investigated the synergic activity of an emulsion, with clarifying-antioxidant activity combined with an activator gel, with hydration and keratolytic activity. 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.

Conditions

Healthy

Keywords

hyperpigmentation; depigmenting treatment; hand

Outcome Measures

Primary Outcomes (1)

• Skin spots image analysis: change from baseline (T2, T4 and T8 vs. T0)

  Skin spots area was measured on the pre-selected images performed with or without Wood's lamp. The measure of skin spots area was performed by means of an image analysis software, with a function called "magic wand". Based on the colour similarities or on the difference of intensity ranges between the selected pixels (with a specified tolerance interval) the magic wand automatically traced the outline of the spot and measured the selected area (pixel2).

  after 2, 4 and 8-week-treatment

Secondary Outcomes (2)

• Spectrophotometric evaluation: change from baseline (T2, T4 and T8 vs. T0)

  after 2, 4 and 8-week-treatment

• Optical colorimetry: change from baseline (T2, T4 and T8 vs. T0)

  after 2, 4 and 8 week-treatment

Study Arms (1)

Emulsion and gel

OTHER

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.

Other: Emulsion and gel

Interventions

Emulsion and gel OTHER

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

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• female healthy subjects
• 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

You may not qualify if:

• pregnancy
• 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

Sponsors & Collaborators

• Derming SRL: lead

Study Sites (1)

DermIng SRL

Monza, Monza, 20900, Italy

Location

Related Publications (18)

• 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.

  PMID: 10583611 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 14561553 BACKGROUND

• 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.

  PMID: 15344467 BACKGROUND

• Curry AS, Gettings SD, McEwen GN CTFA safety testing guidelines. The Cosmetic, Toiletry and Fragrance Association, Washington, 1991

  BACKGROUND

• Fernay, Voltaire The World Medical Association (1989) "World Medical Association Declaration of Helsinki", Hong-Kong

  BACKGROUND

• 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.

  PMID: 8896947 BACKGROUND

• 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.

  PMID: 857837 BACKGROUND

• Gupta LK, Singhi MK. Wood's lamp. Indian J Dermatol Venereol Leprol. 2004 Mar-Apr;70(2):131-5. No abstract available.

  PMID: 17642589 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 17493065 BACKGROUND

• 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.

  PMID: 11952545 BACKGROUND

• Rieger M.M., Battista G.W. Some experiences in the safety testing of cosmetics J. Soc. Cosmet. Chem. 15:161 -172 , 1964

  BACKGROUND

• Rigano L. "Evaluation of the efficacy of a whitening product" ISPE Institute of Skin and Product Evaluation - March 15th 2007

  BACKGROUND

• Sachs L. Applied statistics: a handbook of techniques Heidelberg: Springer, 1981:536-539

  BACKGROUND

• Taelman M-C, Dederen J. C. Relative performance testing of formulations: emulsifiers Cosmetics &Toiletries magazine August 2000; 115: 37-42

  BACKGROUND

• Takiwaki H. Measurement of skin color: practical application and theoretical considerations. J Med Invest. 1998 Feb;44(3-4):121-6.

  PMID: 9597799 BACKGROUND

• 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.

  PMID: 11886508 BACKGROUND

Related Links

• Investigator center
• Sponsor

MeSH Terms

Conditions

Hyperpigmentation

Interventions

Emulsions; Gels

Condition Hierarchy (Ancestors)

Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Adele Sparavigna, Doctor

  Derming SRL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2014
• First Posted: July 30, 2014
• Study Start: November 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: July 30, 2014

Record last verified: 2014-03

Locations

IT (1)