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

August 31, 2017 updated by: Adele Sparavigna, Derming SRL

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • MB
      • Monza, MB, Italy, 20900
        • DermIng S.r.l

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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).

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 month

Secondary Outcome Measures

Outcome Measure
Time Frame
subjects' self assessment
Time Frame: 1 month
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Derming SRL

Investigators

  • Principal Investigator: Adele Sparavigna, Physician, DermIng SRL

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

September 6, 2013

First Submitted That Met QC Criteria

September 19, 2013

First Posted (Estimate)

September 23, 2013

Study Record Updates

Last Update Posted (Actual)

September 1, 2017

Last Update Submitted That Met QC Criteria

August 31, 2017

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E0113

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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