Study of effectiveness and safety of two topical gels CD0271 gel (0.1 % and 0.3 %) in the treatment of acne and post-acne dark spots

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2012/01/002345
• Date of registration: 17-01-2012
• Prospective Registration: Yes
• Primary sponsor: GALDERMA RD SNC
• Public title: Study of effectiveness and safety of two topical gels CD0271 gel (0.1 % and 0.3 %) in the treatment of acne and post-acne dark spots
• Scientific title: Assessment of the efficacy and safety of CD0271 0.1% gel and CD0271 0.3% gel versus vehicle of CD0271 in the treatment of acne and acne-induced post-inflammatory hyperpigmentation
• Date of first enrolment: 20-02-2012
• Target sample size: 40
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=4059
• Study type: Interventional
• Study design: Randomized, Parallel Group, Placebo Controlled Trial; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Participant and Investigator Blinded
• Phase: Phase 2

Countries of recruitment

India, Mauritius

Contacts

• Name: Rashi Nangia
• Affiliation: CIDP Biotech India Pvt. Ltd.

• Name: Dr Sanjeev Miglani
• Affiliation: CIDP Biotech India Pvt. Ltd.

Key inclusion & exclusion criteria

Inclusion criteria: 1.The subject is a male or a female aged 18 to 40 years at Screening visit,

2.The subject has a clinical diagnosis of PIHP on the face, resulting from an active mild to moderate acne vulgaris. To be included subjects must fulfil all following criteria concerning clinical diagnosis of PIHP

3.At least 5 indubitable active inflammatory lesions either papules or pustules or nodules, either pigmented or not and no more than 2 nodules

4.At least 10 hyper pigmented lesions (papules, pustules, nodules or maculas)

5.No more than twice as many hyper pigmented lesions on one side as compared to the other side

6.Mean darkness of hyper pigmented lesions between moderate and severe on a darkness scale of 0 (Normal) to 8 (Severe)

7.Similar mean darkness of the hyper pigmented lesions on each side (+/- 1 grade)

8.At least 3 hyper pigmented lesions with a diameter > 2 mm on each half face.

9.If the subject is a female of childbearing potential, she agrees to be strictly abstinent or to use an effective contraceptive method for the duration of the study and for one month after the last product application. An effective method of contraception is defined as:

-Bilateral tubal ligation.

-Combined oral contraceptives (estrogen and progesterone) on a stable dose for at least 3 months prior to baseline visit.

-Implanted or injectable contraceptives, on a stable dose for at least 3 months prior to baseline visit.

-Hormonal intra-uterine device (IUD), inserted at least 3 months prior to the baseline visit.

-Vasectomized partner for at least 3 months prior to screening visit.

-Condoms

If the female subject is strictly abstinent, she has to be abstinent for at least 1 month prior to screening visit, and, in case she decides to become sexually active, she agrees to use condoms for the duration of the study and for one month after the last products application.



10.If the subject is a female of childbearing potential, she has at screening and baseline a negative result for UPT having a sensitivity down to at least 25 Ul/ml for human chorionic gonadotrophin (hCG) (performed at least 15 days before baseline)

11.If the subject is a female of non-childbearing potential, she has to be postmenopausal (absence of menstrual bleeding for at least one year and without any other medical reason), or presenting with a hysterectomy or a bilateral ovariectomy.

12.The subject is willing and able to comply with the requirements of the protocol. In particular, subject must adhere to the visit schedule and concomitant therapy prohibitions and must be compliant to the treatment,

13.The subject has understood and signed an Informed Consent Form (ICF) at screening visit prior to any investigational procedure.


Exclusion criteria: 1. The subject presents with hypopigmentation related to acne lesions,

2. The subject has been exposed to excessive UV radiations within one month prior to the baseline visit or the subject is planning intense UV exposure during the study (i.e. occupational exposure to the sun, subject used to sunbathing, tanning salon use, phototherapy, etc.)

3. The subject has an underlying disease, which in the investigatorâ??s opinion, could interfere with the study assessments (e.g., other dermatological diseases of the face, such as an atopic dermatitis, eczema, etcâ?¦) or any abrasion, cuts or sunburned skin on the treated area

4. The subject has an underlying disease, which in the investigatorâ??s opinion, could interfere with the study assessments (e.g., other dermatological diseases of the face, such as an atopic dermatitis, eczema, etc.),



Age minimum:
Age maximum:
Gender:

Intervention(s)

Intervention1: CD0271 0.1 %(Adapalene 0.1%): 0.1 % Gel
Topical application 400 mg per half face
once daily application for 5 days a week for 12 weeks (no application on week 12 day 5), total application for 59 days
Intervention2: CD0271 0.3 % (Adapalene 0.3 %): 0.3 % gel
Topical application 400 mg per half face
once daily application for 5 days a week for 12 weeks (no application on week 12 day 5), total application for 59 days
Control Intervention1: Placebo: gel without active drug
Topical application 400 mg per half face
once daily application for 5 days a week for 12 weeks (no application on week 12 day 5), total application for 59 days

Primary Outcome(s)

Mean darkness of lesionsTimepoint: Screening, Inclusion, Week 1(Day5), Week 2 (Day 5), Week 3 (Day 5), Week 4 (Day 5), Week 5 (Day 5), Week 6 (Day 5), Week 7 (Day 5), Week 8 (Day 5), Week 9 (Day 5), Week 10 (Day 5), Week 11 (Day 5), Week 12 (Day 5)

Secondary Outcome(s)

- Count of inflammatory non-pigmented and inflammatory hyper pigmented lesions to analyze the effect on acneTimepoint: Screening, Inclusion, Week 1(Day5), Week 2 (Day 5), Week 3 (Day 5), Week 4 (Day 5), Week 5 (Day 5), Week 6 (Day 5), Week 7 (Day 5), Week 8 (Day 5), Week 9 (Day 5), Week 10 (Day 5), Week 11 (Day 5), Week 12 (Day 5)

colorimetryTimepoint: Inclusion (Day 1), Week 2 (Day 5), Week 4 (Day 5), Week 6 (Day 5), Week 8 (Day 5), Week 10 (Day 5), Week 12 (Day 5)

Total lesions countTimepoint: Screening, Inclusion, Week 1(Day5), Week 2 (Day 5), Week 3 (Day 5), Week 4 (Day 5), Week 5 (Day 5), Week 6 (Day 5), Week 7 (Day 5), Week 8 (Day 5), Week 9 (Day 5), Week 10 (Day 5), Week 11 (Day 5), Week 12 (Day 5)

Investigator global assessmentTimepoint: Screening, Inclusion, Week 1(Day5), Week 2 (Day 5), Week 3 (Day 5), Week 4 (Day 5), Week 5 (Day 5), Week 6 (Day 5), Week 7 (Day 5), Week 8 (Day 5), Week 9 (Day 5), Week 10 (Day 5), Week 11 (Day 5), Week 12 (Day 5)

- Count of inflammatory hyper pigmented lesions and of hyper pigmented maculas to analyse the effect on pigmentationTimepoint: Screening, Inclusion, Week 1(Day5), Week 2 (Day 5), Week 3 (Day 5), Week 4 (Day 5), Week 5 (Day 5), Week 6 (Day 5), Week 7 (Day 5), Week 8 (Day 5), Week 9 (Day 5), Week 10 (Day 5), Week 11 (Day 5), Week 12 (Day 5)

Diameter of hyper pigmented lesionsTimepoint: Screening, Inclusion, Week 1(Day5), Week 2 (Day 5), Week 3 (Day 5), Week 4 (Day 5), Week 5 (Day 5), Week 6 (Day 5), Week 7 (Day 5), Week 8 (Day 5), Week 9 (Day 5), Week 10 (Day 5), Week 11 (Day 5), Week 12 (Day 5)

Subjects global assessmentTimepoint: week 12 (Day 5)

Secondary ID(s)

RD.03.SPR.40164E, Final Version India-23 June 2011

Source(s) of Monetary Support

GALDERMA R&D, SNC Les Templiers 2400 route des Colles BP 87 06410 BIOT FRANCE

Secondary Sponsor(s)

CIDP Biotech India Pvt Ltd

Ethics review

Status: Approved
Approval date: 20/07/2011
Contact:

ALERT EC (IEC)- Mumbai