The hypothesis of this study is that the regular topical application of Oxofulleram in patients with rosacea results in a reduction of the clinical symptoms.
ID
Source
Brief title
Condition
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint:
- the difference in the clinical scores of rosacea of the treated and the
placebo-treated
sides of the face on weeks 2, 4, 6, 8, 10 and 12.
- The difference in the rosacea patients self-evaluation scores of the treated
and the placebo-treated sides of the face on weeks 1, 2, 3, 4, 5, 6, 7, 8, 9,
10, 11 and 12.
Secondary outcome
Side effects
Background summary
Rosacea is a common dermatological condition which is characterized by facial
papulopustels and erythema. Solenne BV has developed a patented fullerene
called Oxofulleram. The cosmetic use of Oxofulleram by patients with rosacea
yielded remarkable positive results. In order to investigate the clinical
potential of Oxofulleram Solenne wants to apply the compound in a clinical
proof of concept pilot study.
Study objective
The hypothesis of this study is that the regular topical application of
Oxofulleram in patients with rosacea results in a reduction of the clinical
symptoms.
Study design
Patients will be recruited from the outpatient clinic of the Department of
Dermatology at the University Medical Center Groningen. At home the patients
will apply Oxofulleram (Combray ®) unilateral twice a day while at the other
side of the face a placebo (grapeseed oil) is applied. Thus, in this study with
a blinded observer, each patient, serves as his or her own control. The
duration of the intervention period is six weeks with a follow up period of six
weeks. The patients are seen by by the researchers every two weeks and
bilaterally scored on the severity and the development of the disease.
Furthermore, the patients weekly fill in a self-evaluation form.
Intervention
The intervention consists of twice daily (morning and evening) unilaterally
applying Oxofulleram (dissolved in grape seed oil) on the face. On the other
side of the face is applied a placebo which consists of grape seed oil.
Study burden and risks
After the intervention period of 6 weeks, there is a follow-up period of 6
weeks to assess the remission of the disease. During the total study duration
of 12 weeks, the patient should refrain from his or her usual medication.
Therefore, it may happen that the patients* face may show a temporary worsening
of the clinical picture.
Zernikepark 6
Groningen 9747 AN
NL
Zernikepark 6
Groningen 9747 AN
NL
Listed location countries
Age
Inclusion criteria
- a diagnosis of papulopustular rosacea;
- the conventional treatments of rosacea should be stopped with a wash-out period of one month;
- age 18-65 years;
- male and female;
- women of childbearing age use double barrier contraception
Exclusion criteria
- Patients with non papulopustular subtypes of rosacea are excluded from the study;
- Patients with other facial dermatoses (acne, perioral dermatitis, eczema);
- Age: younger than 18 and older than 65 years;
- Pregnancy;
- Patients treated with an EGFR inhibitor for an oncological condition are excluded from the study;
- Legally incapable.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2014-004962-76-NL |
| CCMO | NL49195.042.14 |