Clinical Study for the Evaluation of P-3075 Cream on Acne Treatment

Acne Clinical Trial

— ANTI-ACNE  

Official title:

Clinical Study for the Evaluation of P-3075 Cream on Acne Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01948570
• Other study ID #: E0113
• Status: Completed
• Phase: N/A
• First received: September 6, 2013
• Last updated: August 31, 2017
• Start date: March 2013
• Est. completion date: June 2013

Study information

• Verified date: September 2013
• Source: Derming SRL
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acne

Locations

Country	Name	City	State
Italy	DermIng S.r.l	Monza	MB

Sponsors (1)

Lead Sponsor	Collaborator
Derming SRL

Country where clinical trial is conducted

Italy, 

References & Publications (22)

9th international symposium

Adityan B, Kumari R, Thappa DM. Scoring systems in acne vulgaris. Indian J Dermatol Venereol Leprol. 2009 May-Jun;75(3):323-6. doi: 10.4103/0378-6323.51258. Review. — View Citation

Alanen E, Lahtinen T, Nuutinen J. Penetration of electromagnetic fields of an open-ended coaxial probe between 1 MHz and 1 GHz in dielectric skin measurements. Phys Med Biol. 1999 Jul;44(7):N169-76. — View Citation

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

Cunliffe WJ, Shuster S. The rate of sebum excretion in man. Br J Dermatol. 1969 Sep;81(9):697-704. — View Citation

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

International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use. ICH harmonized tripartite guideline: Guideline for Good Clinical Practice. J Postgrad Med. 2001 Jan-Mar;47(1):45-50. — View Citation

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. Phys Med Biol. 1997 Jul;42(7):1471-2. — View Citation

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

Mayrovitz HN, Luis M. Spatial variations in forearm skin tissue dielectric constant. Skin Res Technol. 2010 Nov;16(4):438-43. doi: 10.1111/j.1600-0846.2010.00456.x. — View Citation

Piérard GE, Piérard-Franchimont C, Lê T, Lapière C. Patterns of follicular sebum excretion rate during lifetime. Arch Dermatol Res. 1987;279 Suppl:S104-7. — View Citation

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

Thune P, Gustavsen T. Comparison of two photoelectric techniques for quantitative measurements of skin surface lipids. Acta Derm Venereol Suppl (Stockh). 1987;134:30-2. — View Citation

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

* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical and non-invasive instrumental evaluation of the activity of P-3075 cream on subjects with acne	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	1 month
Secondary	subjects' self assessment		1 month

External Links

•   Investigation center
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