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

Information source: Derming SRL
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acne

Phase: N/A

Status: Completed

Sponsored by: Derming SRL

Official(s) and/or principal investigator(s):
Adele Sparavigna, Physician, Principal Investigator, Affiliation: Derming SRL

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.

Clinical Details

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

Study design: Observational Model: Case Control, Time Perspective: Prospective

Primary outcome: clinical and non-invasive instrumental evaluation of the activity of P-3075 cream on subjects with acne

Secondary outcome: subjects' self assessment

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.

Eligibility

Minimum age: 16 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

DermIng S.r.l, Monza, MB 20900, Italy
Additional Information

Starting date: March 2013
Last updated: September 19, 2013

Page last updated: August 23, 2015

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