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

NCT ID: NCT01948570

Last Updated: 2017-09-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2013-06-30

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.

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.

Conditions

Acne

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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).

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility 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.

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Derming SRL

OTHER

Sponsor Role: lead

Responsible Party

Adele Sparavigna

Dermatologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Adele Sparavigna, Physician

Role: PRINCIPAL_INVESTIGATOR

Derming SRL

Locations

DermIng S.r.l

Monza, MB, Italy

Countries

Italy

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9th international symposium

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Related Links

http://www.polichem.com

Text sponsor

Other Identifiers

E0113

Identifier Type: -

Identifier Source: org_study_id