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Clinical Study for the Evaluation of P-3075 Cream on Acne Treatment (ANTI-ACNE)

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ClinicalTrials.gov Identifier: NCT01948570
Recruitment Status : Completed
First Posted : September 23, 2013
Last Update Posted : September 1, 2017
Sponsor:
Information provided by (Responsible Party):
Adele Sparavigna, Derming SRL

Brief Summary:

Primary end point of the study is the clinical and non-invasive instrumental evaluation of the activity of P-3075 cream on subjects with acne: 20 subjects with a mild/moderate grade and 20 subjects with a moderately severe/severe grade, according to Cunliffe' classification.

Secondary end-points are the cosmetic acceptability and efficacy evaluation by the volunteers and the local tolerability assessed by the investigator and the subjects.


Condition or disease
Acne

Detailed Description:

This is an open controlled clinical trial. The product will be applied for a period of 4 weeks and 3 visits will be performed: a baseline visit (T0), an intermediate visit after 2 weeks (T2) and a final visit after 4 week-treatment (T4).

The subjects will be enrolled and divided in 2 groups according to their acne grade (20 subjects with mild/moderate grade and 20 subjects with moderately severe/severe), a concomitant therapy is allowed only for volunteers with acne moderately severe/severe.

Each volunteer, fulfilling the inclusion criteria, will perform a cosmetic treatment with the study product on all the face, for 4 weeks.

A fixed quantity of the medical device will be applied on the face twice a day, in the morning and in the evening (always at the same hour), with a mild massage according to the instructions received by the investigator during the baseline visit (T0). Group 2 will continue also the standardised treatment with topical or systemic retinoids, benzoyl peroxide, clindamycin or AHA until the end of the study.


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Study Type : Observational [Patient Registry]
Actual Enrollment : 40 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 2 Months
Official Title: Clinical Study for the Evaluation of P-3075 Cream on Acne Treatment
Study Start Date : March 2013
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Group/Cohort
not in therapy (GROUP 1)
A fixed quantity of the medical device will be applied on the face twice a day, in the morning and in the evening (always at the same hour), with a mild massage according to the instructions received by the investigator during the baseline visit (T0).
in therapy (GROUP 2)
A fixed quantity of the medical device will be applied on the face twice a day, in the morning and in the evening (always at the same hour), with a mild massage according to the instructions received by the investigator during the baseline visit (T0). Group 2 will continue also the standardised treatment with topical or systemic retinoids, benzoyl peroxide, clindamycin or AHA until the end of the study



Primary Outcome Measures :
  1. clinical and non-invasive instrumental evaluation of the activity of P-3075 cream on subjects with acne [ Time Frame: 1 month ]
    Visual evaluations (comedones, dryness, desquamation, papules, pustoles, microcystis) Tissue dielectric constant (superficial and deep hydration), sebumetry and optical colorimetry (skin colour), follicular biopsy, sebutape image analysis


Secondary Outcome Measures :
  1. subjects' self assessment [ Time Frame: 1 month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
The study will be conducted on volunteers of both genders, aged > 16 years old: 20 subjects presenting acne of mild/moderate grade not in therapy (GROUP 1) and 20 subjects presenting acne of moderately severe/severe grade in therapy with topical or systemic retinoids, benzoyl peroxide, clindamycin or AHA (GROUP 2).
Criteria

Inclusion Criteria:

  • both genders;
  • age > 16 years old;
  • acne of mild/moderate grade, not in therapy (GROUP 1);
  • acne of moderately severe/severe grade, in therapy with topical or systemic retinoids, benzoyl peroxide, clindamycin or AHA (GROUP 2);
  • accepting to follow the instructions received by the investigator;
  • available to return to the study centre at the protocol visits;
  • accepting to not change the normal life habits regarding: food, physical activity, face cleansing;
  • accepting not to receive any other drug/cosmetic treatment able to interfere with the study results;
  • accepting to sign the informed consent form (under 18 years the signature of both parents is required).

Exclusion Criteria:

  • Pregnancy (only for female subjects) - for subjects belonging to Group 2, a control pregnancy test could be required at T2 and T4 in case of assumption of an anti-acne drug with potential teratogenic effects; these subjects must confirm to use adequate contraceptive precautions in order to avoid pregnancies;
  • lactation (only for female subjects);
  • subjects whose insufficient adhesion to the study protocol is expected;
  • subjects who changed the anti-acne therapy during the 2 months prior to the study inclusion;
  • concomitant participation in other studies or in the last 3 months.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01948570


Locations
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Italy
DermIng S.r.l
Monza, MB, Italy, 20900
Sponsors and Collaborators
Derming SRL
Investigators
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Principal Investigator: Adele Sparavigna, Physician Derming SRL

Additional Information:
Publications:
Becker W.D., Bajor J.S., Hoyberg K., Hillmer S., Thibouto D., Knaggs H. Measurement Of Human Surface Sebum Levels The Journal of Investigative Dermatology, Vol. 110, No. 4, April 1998
Clarys P.M., Barel A.O. Sebumetry: A comparison between Lipid Collection Techniques. Skin Research and Technology, Vol.2, No.4, Nov.1996
Curry AS, Gettings SD, McEwen GN CTFA safety testing guidelines. The Cosmetic, Toiletry and Fragrance Association, Washington, (1991)
Elsner P. Sebum Bioengineering of the Skin: Methods and Instrumentation, CRC Press 1995
Fernay, Voltaire The World Medical Association (1989) "World Medical Association Declaration of Helsinki", Hong-Kong
Kiiskinen M., Nuutinen J. and Alanen E. Measurement depths of a skin-water analyzer (MoistureMeter D) Skin Res Technol, Vol 11: 292, 2005
Klingman A.M., Miller D.L., McGinley K.J. Sebutape: A device for visualizing and measuring human sebaceous secretion. J. Soc. Cosmet. Chem. 37:369-374, 1896
Lahtinen, T., Nuutinen, J., Alanen, E. Dielectric properties of the skin In: Radio Frequency Radiation Dosimetry. Editors: B. J. Klauenberg and D. Miklavcic. Kluwer Academic Publishers, the Netherlands, 2000
Rieger M.M., Battista G.W. Some experiences in the safety testing of cosmetics J. Soc. Cosmet. Chem. 15:161 -172 (1964)
Sachs L. Applied statistics: a handbook of techniques. Heidelberg: Springer, 1981:536-539
Sparavigna A. Un metodo di valutazione della secrezione sebacea a livello dei singoli follicoli: il Sebutape. Cosmesi Dermatologica 30: 73-75, 1990
Van de Vijver LPL, Boelsma E, Bausch-Goldbohm RA, Roza L. Subjective skin condition and its association with objective skin measurements. Cosm Toil 2003: 118: 45-54
Wilhelm KP, Elsner P, Berardesca E, Maibach HI Bioengineering of the skin: Skin surface imaging and analysis. CRC Press, Boca Raton, 1997
9th international symposium

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Responsible Party: Adele Sparavigna, Dermatologist, Derming SRL
ClinicalTrials.gov Identifier: NCT01948570     History of Changes
Other Study ID Numbers: E0113
First Posted: September 23, 2013    Key Record Dates
Last Update Posted: September 1, 2017
Last Verified: September 2013
Keywords provided by Adele Sparavigna, Derming SRL:
acne,comedones, oily skin
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Benzoyl Peroxide
Dermatologic Agents